FDA product code JMM: Column Chromatography & Color Development, Hydroxyproline
JMM is the FDA product code for column chromatography & color development, hydroxyproline. It is a Class I device, regulated under 21 CFR 862.1400 and reviewed by the Clinical Chemistry panel. FDA has cleared 21 510(k) submissions under JMM, from 12 different applicants. The average 510(k) review took 134 days (median 115). FDA has posted 2 recalls for JMM devices.
Classification
| Field | Value |
|---|---|
| Device name | Column Chromatography & Color Development, Hydroxyproline |
| Device class | Class I |
| Regulation | 21 CFR 862.1400 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JMM clearance
Top JMM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ostex Intl., Inc. | 5 | 2001-07-30 |
| Metra Biosystems, Inc. | 5 | 1998-08-13 |
| Diagnostic Products Corp. | 2 | 1998-05-01 |
| Roche Diagnostics Corp. | 1 | 2000-07-24 |
| Metrika, Inc. | 1 | 1999-11-09 |
7 more applicants have JMM clearances. See the full list in Caduvo.
Most recent JMM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011052 | Ostex Intl., Inc. | OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE | 2001-07-30 | 115 |
| K993706 | Roche Diagnostics Corp. | ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY | 2000-07-24 | 265 |
| K992997 | Metrika, Inc. | OSTEOMARK NTX POC | 1999-11-09 | 63 |
| K990843 | Osteometer Biotech A/S | SERUM CROSSLAPS ONE STEP ELISA | 1999-07-09 | 116 |
| K983457 | Ostex Intl., Inc. | OSTEOMARK NTX SERUM EIA | 1999-02-02 | 125 |
Recalls for JMM devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-04-25.
Frequently asked questions
What is FDA product code JMM?
JMM is the FDA product code for column chromatography & color development, hydroxyproline. It is a Class I device, regulated under 21 CFR 862.1400 and reviewed by the Clinical Chemistry panel.
What device class is JMM?
Class I, regulation 21 CFR 862.1400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JMM?
Across 21 cleared submissions the average was 134 days from receipt to decision (median 115).
Which companies have the most JMM clearances?
Ostex Intl., Inc. (5); Metra Biosystems, Inc. (5); Diagnostic Products Corp. (2); Roche Diagnostics Corp. (1); Metrika, Inc. (1).
Have JMM devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2013-04-25.
Next steps
- Run an FDA pathway report with predicate devices for product code JMM
- Run a recall and safety report across every JMM manufacturer
- Watch product code JMM 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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