FDA product code JIT: Calibrator, Secondary
JIT is the FDA product code for calibrator, secondary. It is a Class II device, regulated under 21 CFR 862.1150 and reviewed by the Clinical Chemistry panel. FDA has cleared 245 510(k) submissions under JIT, from 95 different applicants. The average 510(k) review took 59 days (median 41). FDA has posted 55 recalls for JIT devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Calibrator, Secondary |
| Device class | Class II |
| Regulation | 21 CFR 862.1150 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
510(k) clearances per year for JIT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 27 |
Compare with all 510(k) review times · Search every JIT clearance
Top JIT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dade Behring, Inc. | 29 | 2007-12-12 |
| Wako Chemicals USA, Inc. | 15 | 2004-04-23 |
| Roche Diagnostics Corp. | 10 | 2006-04-18 |
| E.I. Dupont DE Nemours & Co., Inc. | 10 | 1994-03-11 |
| Diamond Diagnostics, Inc. | 9 | 2014-08-08 |
90 more applicants have JIT clearances. See the full list in Caduvo.
Most recent JIT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171168 | Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products Insulin Calibrators | 2017-05-16 | 25 |
| K170938 | Roche Diagnostics | CalSet IGF-1 | 2017-04-26 | 27 |
| K170160 | Abbott Laboratories | Abbott ARCHITECT Free T3 | 2017-02-15 | 28 |
| K163534 | Fujirebio Diagnostics,Inc. | Lumipulse G FSH-N Calibrators | 2017-01-13 | 28 |
| K163546 | Fujirebio Diagnostics,Inc. | Lumipulse G Progesterone-N Calibrators | 2017-01-13 | 28 |
Recalls for JIT devices
55 product recalls in 41 recall events; 9 initiated in the last five years and 12 still open. Most recent: 2026-07-01.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 6 |
| 2019 | 8 |
| 2020 | 4 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 4 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code JIT?
JIT is the FDA product code for calibrator, secondary. It is a Class II device, regulated under 21 CFR 862.1150 and reviewed by the Clinical Chemistry panel.
What device class is JIT?
Class II, regulation 21 CFR 862.1150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JIT?
Across 245 cleared submissions the average was 59 days from receipt to decision (median 41).
Which companies have the most JIT clearances?
Dade Behring, Inc. (29); Wako Chemicals USA, Inc. (15); Roche Diagnostics Corp. (10); E.I. Dupont DE Nemours & Co., Inc. (10); Diamond Diagnostics, Inc. (9).
Have JIT devices been recalled?
Yes: 55 product recalls across 41 recall events; the most recent began 2026-07-01.
Next steps
- Run an FDA pathway report with predicate devices for product code JIT
- Run a recall and safety report across every JIT manufacturer
- Watch product code JIT 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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