FDA product code · Clinical Chemistry
CHHEnzymatic Esterase--Oxidase, Cholesterol
Product code CHH covers Enzymatic Esterase--Oxidase, Cholesterol, a Class I device regulated under 21 CFR 862.1175. FDA has cleared 230 devices in this code, 1 of them in the last 12 months. Median review time across the 230 most recent decisions is 50 days. openFDA lists 23 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 862.1175
- Review panel
- Clinical Chemistry
- Clearances
- 230
What is happening in CHH right now?
CHH (Enzymatic Esterase--Oxidase, Cholesterol) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2085-2026). 1 first-time filer in the last 12 months, Truvian Health (K251091). The code is crowded, scoring 67 of 100 — 128 companies hold a clearance here and 1 arrived in the last 12 months (CHH:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2085-2026 |
| New entrant | Worth knowing | K251091 |
| Crowding | Context | CHH:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in CHH?
FDA has cleared 230 devices under product code CHH since the 510(k) programme began in 1976, 1 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251091 | Lipids | Truvian Health | |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES | Medicon Hellas S.A | |
| K203597 | Cholesterol2 | Abbott Ireland Diagnostics Division | |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | Ortho-Clinical Diagnostics, Inc. | |
| K181373 | Extended Lipid Panel Assay | Laboratory Corporation of America Holdings | |
| K180504 | Mission Lipid Panel Monitoring System | ACON Laboratories, Inc. | |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System | ACON Laboratories, Inc. | |
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System | Polymer Technology Systems, Inc. | |
| K150654 | Cholesterol | Randox Laboratories, Ltd. | |
| K132031 | AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL | Axis-Shield Poc AS |
How long does FDA review take for CHH?
The median FDA review time for CHH is 50 days, measured across the 230 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in CHH?
openFDA lists 23 recall records against product code CHH. A recall record covers one firm's corrective action and may span many device lots.
Z-2085-2026Open, ClassifiedDFI Co., Ltd.
The devices were distributed without required FDA premarket clearance or approval.
Z-1424-2022TerminatedRandox Laboratories, Limited
Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.
Z-0399-2022Open, ClassifiedBeckman Coulter, Inc.
Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.
Z-0328-2022TerminatedRandox Laboratories, Limited
When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range
Z-2157-2019TerminatedPolymer Technology Systems, Inc.
The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
Showing the 5 most recently initiated of 23. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for CHH?
MAUDE holds 30 adverse-event reports naming product code CHH, 12 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in CHH unusual?
CHH does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
19 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered CHH in the last year?
One company filed in CHH for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Truvian Health | K251091 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in CHH?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in CHH?
Across the 230 most recent decisions, these applicants filed most often in CHH.
| Applicant | Recent clearances |
|---|---|
| Cholestech Corp. | 10 |
| Em Diagnostic Systems, Inc. | 10 |
| Beckman Instruments, Inc. | 7 |
| Boehringer Mannheim Corp. | 7 |
| Polymer Technology Systems, Inc. | 7 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch CHH
Get an email the morning anything changes in CHH — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.