FDA product code · Hematology
JPKMixture, Hematology Quality Control
Product code JPK covers Mixture, Hematology Quality Control, a Class II device regulated under 21 CFR 864.8625. FDA has cleared 192 devices in this code. Median review time across the 192 most recent decisions is 45 days. openFDA lists 16 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 864.8625
- Review panel
- Hematology
- Clearances
- 192
What is happening in JPK right now?
JPK (Mixture, Hematology Quality Control): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in JPK?
FDA has cleared 192 devices under product code JPK since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160590 | XN CHECK | Streck | |
| K160588 | XN CHECK BF | Streck | |
| K160586 | XN-L CHECK | Streck | |
| K160606 | BC-5D Hematology Control | R&D Systems, Inc. | |
| K141964 | XN CHECK | Streck | |
| K141957 | XN CHECK BF | Streck | |
| K130962 | R&D 5D RETIC HEMATOLOGY CONTROL | R&D Systems, Inc. | |
| K120744 | XN CHECK BF | Streck | |
| K120742 | XN CHECK | Streck | |
| K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL | R&D Systems, Inc. |
How long does FDA review take for JPK?
The median FDA review time for JPK is 45 days, measured across the 192 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 JPK?
openFDA lists 16 recall records against product code JPK. A recall record covers one firm's corrective action and may span many device lots.
Z-0999-2023TerminatedR & D Systems, Inc.
For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
Z-0349-2023TerminatedPrimus Corporation dba Trinity Biotech
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.
Z-0350-2023TerminatedPrimus Corporation dba Trinity Biotech
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.
Z-1249-2021TerminatedMedline Industries, LP
Product was compromised during shipment.
Z-0562-2021TerminatedBecton, Dickinson and Company, BD Biosciences
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
Showing the 5 most recently initiated of 16. 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 JPK?
MAUDE holds 2 adverse-event reports naming product code JPK.
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
What are the predicate devices in JPK?
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 JPK?
Across the 192 most recent decisions, these applicants filed most often in JPK.
| Applicant | Recent clearances |
|---|---|
| R&D Systems, Inc. | 45 |
| Streck Laboratories, Inc. | 23 |
| Streck | 12 |
| Beckman Coulter, Inc. | 10 |
| Coulter Electronics, Inc. | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch JPK
Get an email the morning anything changes in JPK — 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.