FDA product code JPI: Device, Hematocrit Measuring
JPI is the FDA product code for device, hematocrit measuring. It is a Class II device, regulated under 21 CFR 864.6400 and reviewed by the Hematology panel. FDA has cleared 15 510(k) submissions under JPI, from 13 different applicants. The average 510(k) review took 98 days (median 47). FDA has posted 9 recalls for JPI devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Hematocrit Measuring |
| Device class | Class II |
| Regulation | 21 CFR 864.6400 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for JPI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 266 |
| 2020 | 1 | 427 |
Compare with all 510(k) review times · Search every JPI clearance
Top JPI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Norfolk Scientific, Inc. | 2 | 1990-06-20 |
| Fisher Scientific Co., LLC | 2 | 1983-03-24 |
| Abbott Point of Care, Inc. | 1 | 2020-02-28 |
| Abbott Laboratories | 1 | 2017-08-22 |
| In-Line Diagnostics Corp. | 1 | 1995-03-14 |
8 more applicants have JPI clearances. See the full list in Caduvo.
Most recent JPI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183680 | Abbott Point of Care, Inc. | i-STAT CHEM8+ cartridge with the i-STAT 1 System | 2020-02-28 | 427 |
| K163342 | Abbott Laboratories | i-STAT Hematocrit test with i-STAT Alinity System | 2017-08-22 | 266 |
| K950942 | In-Line Diagnostics Corp. | CRIT-LINE HEMATOCRIT ALERT | 1995-03-14 | 27 |
| K924167 | Noninvasive Medical Technology Corp. | CRIT-LINE | 1993-05-07 | 261 |
| K903698 | Statspin Technologies | STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES | 1990-09-17 | 33 |
Recalls for JPI devices
9 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-02-05.
Frequently asked questions
What is FDA product code JPI?
JPI is the FDA product code for device, hematocrit measuring. It is a Class II device, regulated under 21 CFR 864.6400 and reviewed by the Hematology panel.
What device class is JPI?
Class II, regulation 21 CFR 864.6400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JPI?
Across 15 cleared submissions the average was 98 days from receipt to decision (median 47).
Which companies have the most JPI clearances?
Norfolk Scientific, Inc. (2); Fisher Scientific Co., LLC (2); Abbott Point of Care, Inc. (1); Abbott Laboratories (1); In-Line Diagnostics Corp. (1).
Have JPI devices been recalled?
Yes: 9 product recalls across 2 recall events; the most recent began 2010-02-05.
Next steps
- Run an FDA pathway report with predicate devices for product code JPI
- Run a recall and safety report across every JPI manufacturer
- Watch product code JPI 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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