FDA product code JJT: Enzyme Controls (Assayed And Unassayed)
JJT is the FDA product code for enzyme controls (assayed and unassayed). It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel. FDA has cleared 97 510(k) submissions under JJT, from 54 different applicants. The average 510(k) review took 45 days (median 32). FDA has posted 2 recalls for JJT devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Controls (Assayed And Unassayed) |
| Device class | Class I |
| Regulation | 21 CFR 862.1660 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJT clearance
Top JJT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 7 | 1995-04-20 |
| Bio-Rad | 6 | 2002-05-24 |
| Cala Diagnostics | 6 | 1994-10-31 |
| Helena Laboratories | 4 | 1995-03-30 |
| Dade, Baxter Travenol Diagnostics, Inc. | 4 | 1978-06-13 |
49 more applicants have JJT clearances. See the full list in Caduvo.
Most recent JJT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K090940 | Astoria-Pacific, Inc. | SPOTCHECK BLOOD SPOT CONTROL, ASSAYED | 2009-12-14 | 255 |
| K062751 | Quantimetrix Corp. | MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER | 2006-10-03 | 19 |
| K030768 | Cliniqa Corporation | CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL | 2003-03-21 | 10 |
| K030102 | Bayer Healthcare, LLC | ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 | 2003-01-24 | 14 |
| K021498 | Bio-Rad | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL | 2002-05-24 | 15 |
Recalls for JJT devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-07-19.
Frequently asked questions
What is FDA product code JJT?
JJT is the FDA product code for enzyme controls (assayed and unassayed). It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Clinical Chemistry panel.
What device class is JJT?
Class I, regulation 21 CFR 862.1660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJT?
Across 97 cleared submissions the average was 45 days from receipt to decision (median 32).
Which companies have the most JJT clearances?
Beckman Instruments, Inc. (7); Bio-Rad (6); Cala Diagnostics (6); Helena Laboratories (4); Dade, Baxter Travenol Diagnostics, Inc. (4).
Have JJT devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2012-07-19.
Next steps
- Run an FDA pathway report with predicate devices for product code JJT
- Run a recall and safety report across every JJT manufacturer
- Watch product code JJT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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