FDA product code · Microbiology
JTODiscs, Strips And Reagents, Microorganism Differentiation
Product code JTO covers Discs, Strips And Reagents, Microorganism Differentiation, a Class I device regulated under 21 CFR 866.2660. FDA has cleared 244 devices in this code. Median review time across the 244 most recent decisions is 39 days. openFDA lists 21 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 866.2660
- Review panel
- Microbiology
- Clearances
- 244
What is happening in JTO right now?
JTO (Discs, Strips And Reagents, Microorganism Differentiation): 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 JTO?
FDA has cleared 244 devices under product code JTO since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050352 | IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT | Ameritek Research, LLC | |
| K970832 | PYR SWAB | Remel, Inc. | |
| K970834 | GRAM SWAB | Remel, Inc. | |
| K970833 | INDOLE SWAB | Remel, Inc. | |
| K970009 | LYFO(TM) DIFFERENTIAL DISK-BACITRACIN | Microbiologics, Inc. | |
| K962966 | IDS RAPID CB PLUS SYSTEM | Innovative Diagnostic Systems, Inc. | |
| K961191 | COLISCREEN | Hardy Diagnostics | |
| K960996 | M. CAT BUTYRATE DISK | Hardy Diagnostics | |
| K955826 | GIBSON ID-M. CAT. | Gibson Laboratories, Inc. | |
| K954783 | DRYSLIDE CARTARRHALIS | Difco Laboratories, Inc. |
How long does FDA review take for JTO?
The median FDA review time for JTO is 39 days, measured across the 244 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 JTO?
openFDA lists 21 recall records against product code JTO. A recall record covers one firm's corrective action and may span many device lots.
Z-0783-2023Open, ClassifiedbioMerieux, Inc.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0805-2023Open, ClassifiedbioMerieux, Inc.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0806-2023Open, ClassifiedbioMerieux, Inc.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0807-2023Open, ClassifiedbioMerieux, Inc.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0808-2023Open, ClassifiedbioMerieux, Inc.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Showing the 5 most recently initiated of 21. 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 JTO?
MAUDE holds 20 adverse-event reports naming product code JTO.
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 JTO unusual?
JTO 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 | |
| 5 | 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 |
12 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.
What are the predicate devices in JTO?
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 JTO?
Across the 244 most recent decisions, these applicants filed most often in JTO.
| Applicant | Recent clearances |
|---|---|
| Remel Co. | 46 |
| Difco Laboratories, Inc. | 34 |
| Dms Laboratories | 13 |
| Austin Biological Laboratories | 12 |
| E-Y Laboratories, Inc. | 11 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in JTO files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Remel, Inc. | 49 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch JTO
Get an email the morning anything changes in JTO — 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.