FDA product code JBQ: Antithrombin Iii Quantitation
JBQ is the FDA product code for antithrombin iii quantitation. It is a Class II device, regulated under 21 CFR 864.7060 and reviewed by the Hematology panel. FDA has cleared 56 510(k) submissions under JBQ, 1 in the last five years, from 40 different applicants. The average 510(k) review took 102 days (median 62); 184 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Antithrombin Iii Quantitation |
| Device class | Class II |
| Regulation | 21 CFR 864.7060 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JBQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 184 |
Compare with all 510(k) review times · Search every JBQ clearance
Top JBQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumentation Laboratory CO | 9 | 2007-02-23 |
| Beckman Instruments, Inc. | 2 | 1997-12-24 |
| Sigma Diagnostics, Inc. | 2 | 1997-07-25 |
| Helena Laboratories | 2 | 1995-11-13 |
| American Bioproducts Co. | 2 | 1995-04-07 |
35 more applicants have JBQ clearances. See the full list in Caduvo.
Most recent JBQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242952 | Siemens Healthcare Diagnostic Products GmbH | INNOVANCE Antithrombin | 2025-03-28 | 184 |
| K081769 | Siemens Healthcare Diagnostics | INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 | 2009-05-28 | 339 |
| K070301 | Instrumentation Laboratory CO | HEMOSIL ANTITHROMBIN | 2007-02-23 | 23 |
| K062431 | Instrumentation Laboratory CO | HEMOSIL LIQUID ANTITHROMBIN | 2006-09-01 | 11 |
| K043007 | Hyphen Biomed | BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 | 2005-11-07 | 371 |
Recalls for JBQ devices
openFDA lists no recalls for product code JBQ.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J7197 — Antithrombin iii (human), per i.u.
Frequently asked questions
What is FDA product code JBQ?
JBQ is the FDA product code for antithrombin iii quantitation. It is a Class II device, regulated under 21 CFR 864.7060 and reviewed by the Hematology panel.
What device class is JBQ?
Class II, regulation 21 CFR 864.7060. Typical premarket route: 510(k).
How long does a 510(k) take for product code JBQ?
Across 56 cleared submissions the average was 102 days from receipt to decision (median 62).
Which companies have the most JBQ clearances?
Instrumentation Laboratory CO (9); Beckman Instruments, Inc. (2); Sigma Diagnostics, Inc. (2); Helena Laboratories (2); American Bioproducts Co. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code JBQ
- Run a recall and safety report across every JBQ manufacturer
- Watch product code JBQ 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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