FDA product code JJJ: Counter (Beta, Gamma) For Clinical Use
JJJ is the FDA product code for counter (beta, gamma) for clinical use. It is a Class I device, regulated under 21 CFR 862.2320 and reviewed by the Clinical Chemistry panel. FDA has cleared 63 510(k) submissions under JJJ, from 30 different applicants. The average 510(k) review took 60 days (median 42). FDA has posted 14 recalls for JJJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Counter (Beta, Gamma) For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2320 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJJ clearance
Top JJJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 7 | 1981-12-29 |
| Kemble Instruments, Inc. | 6 | 1983-10-14 |
| Lkb Instruments, Inc. | 5 | 1987-11-04 |
| Abbott Laboratories | 4 | 1992-03-19 |
| Micromedic Systems | 4 | 1986-08-04 |
25 more applicants have JJJ clearances. See the full list in Caduvo.
Most recent JJJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962762 | Biotraces, Inc. | SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR | 1996-08-16 | 31 |
| K946387 | Capintec, Inc. | CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER | 1995-03-30 | 125 |
| K920559 | Abbott Laboratories | ABBOTT VERTEX ANALYZER | 1992-03-19 | 41 |
| K900087 | Laboratory Technologies, Inc. | GENESYS 6000 GAMMA COUNTER | 1990-07-19 | 195 |
| K896202 | Canberra Industries, Inc. | MATRIX(TM)-96 | 1990-01-02 | 68 |
Recalls for JJJ devices
14 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-12-08.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J0888 — Injection, epoetin beta, 1 microgram, (for non esrd use)
Frequently asked questions
What is FDA product code JJJ?
JJJ is the FDA product code for counter (beta, gamma) for clinical use. It is a Class I device, regulated under 21 CFR 862.2320 and reviewed by the Clinical Chemistry panel.
What device class is JJJ?
Class I, regulation 21 CFR 862.2320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJJ?
Across 63 cleared submissions the average was 60 days from receipt to decision (median 42).
Which companies have the most JJJ clearances?
Beckman Instruments, Inc. (7); Kemble Instruments, Inc. (6); Lkb Instruments, Inc. (5); Abbott Laboratories (4); Micromedic Systems (4).
Have JJJ devices been recalled?
Yes: 14 product recalls across 2 recall events; the most recent began 2015-12-08.
Next steps
- Run an FDA pathway report with predicate devices for product code JJJ
- Run a recall and safety report across every JJJ manufacturer
- Watch product code JJJ 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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