FDA product code JIW: Calibrator, Surrogate
JIW is the FDA product code for calibrator, surrogate. It is a Class II device, regulated under 21 CFR 862.1150 and reviewed by the Clinical Chemistry panel. FDA has cleared 17 510(k) submissions under JIW, from 16 different applicants. The average 510(k) review took 66 days (median 59).
Classification
| Field | Value |
|---|---|
| Device name | Calibrator, Surrogate |
| Device class | Class II |
| Regulation | 21 CFR 862.1150 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JIW clearance
Top JIW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Union Carbide Corp. | 2 | 1980-03-12 |
| Wako Chemicals USA, Inc. | 1 | 1997-09-25 |
| Dade Chemistry Systems, Inc. | 1 | 1997-02-20 |
| Sigma Diagnostics, Inc. | 1 | 1991-04-03 |
| Diagnostic Products Corp. | 1 | 1990-10-04 |
11 more applicants have JIW clearances. See the full list in Caduvo.
Most recent JIW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973055 | Wako Chemicals USA, Inc. | WAKO CH50 LINEARITY SET | 1997-09-25 | 41 |
| K970396 | Dade Chemistry Systems, Inc. | HUMAN CHORIONIC GONADOTROPIN CALIBRATOR | 1997-02-20 | 17 |
| K910255 | Sigma Diagnostics, Inc. | FLOW CYTOMETRY FITC/PE COMPENSATION KIT | 1991-04-03 | 71 |
| K902575 | Diagnostic Products Corp. | SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) | 1990-10-04 | 115 |
| K902294 | Sigma Chemical Co. | ACCUSCAN MICROBEAD STANDARDS | 1990-07-03 | 42 |
Recalls for JIW devices
openFDA lists no recalls for product code JIW.
Frequently asked questions
What is FDA product code JIW?
JIW is the FDA product code for calibrator, surrogate. It is a Class II device, regulated under 21 CFR 862.1150 and reviewed by the Clinical Chemistry panel.
What device class is JIW?
Class II, regulation 21 CFR 862.1150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JIW?
Across 17 cleared submissions the average was 66 days from receipt to decision (median 59).
Which companies have the most JIW clearances?
Union Carbide Corp. (2); Wako Chemicals USA, Inc. (1); Dade Chemistry Systems, Inc. (1); Sigma Diagnostics, Inc. (1); Diagnostic Products Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JIW
- Run a recall and safety report across every JIW manufacturer
- Watch product code JIW 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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