FDA product code JQC: Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
JQC is the FDA product code for centrifuges (micro, ultra, refrigerated) for clinical use. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 38 510(k) submissions under JQC, from 27 different applicants. The average 510(k) review took 48 days (median 36). FDA has posted 16 recalls for JQC devices.
Classification
| Field | Value |
|---|---|
| Device name | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
510(k) clearances per year for JQC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 192 |
Compare with all 510(k) review times · Search every JQC clearance
Top JQC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Norfolk Scientific, Inc. | 3 | 1988-04-05 |
| E.I. Dupont DE Nemours & Co., Inc. | 3 | 1986-04-14 |
| Lkb Instruments, Inc. | 3 | 1983-07-29 |
| Harvest Technologies, Corp. | 2 | 2010-12-06 |
| Perfusion Partners & Assoc., Inc. | 2 | 2007-06-20 |
22 more applicants have JQC clearances. See the full list in Caduvo.
Most recent JQC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183205 | Emcyte Corporation | PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System | 2019-05-30 | 192 |
| K103340 | Harvest Technologies, Corp. | SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM | 2010-12-06 | 21 |
| K081345 | Thermogenesis Corp. | AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY) | 2008-07-10 | 57 |
| K071934 | Biomet Manufacturing Corp | MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT | 2007-10-11 | 90 |
| K070666 | Perfusion Partners & Assoc., Inc. | GENESISCS COMPONENT CONCENTRATING SYSTEM | 2007-06-20 | 100 |
Recalls for JQC devices
16 product recalls in 13 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-02-06.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2019 | 3 |
Frequently asked questions
What is FDA product code JQC?
JQC is the FDA product code for centrifuges (micro, ultra, refrigerated) for clinical use. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is JQC?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JQC?
Across 38 cleared submissions the average was 48 days from receipt to decision (median 36).
Which companies have the most JQC clearances?
Norfolk Scientific, Inc. (3); E.I. Dupont DE Nemours & Co., Inc. (3); Lkb Instruments, Inc. (3); Harvest Technologies, Corp. (2); Perfusion Partners & Assoc., Inc. (2).
Have JQC devices been recalled?
Yes: 16 product recalls across 13 recall events; the most recent began 2019-02-06.
Next steps
- Run an FDA pathway report with predicate devices for product code JQC
- Run a recall and safety report across every JQC manufacturer
- Watch product code JQC 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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