Metrika, Inc.: FDA clearances and approvals
Metrika, Inc. has 11 FDA 510(k) clearances (first 1999, latest 2005), across 5 product codes in 2 review panels. Median 510(k) review time: 63 days. openFDA lists 1 product recall by a recalling firm named Metrika, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | 7 | 7 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 1 |
| JFY | Enzymatic Method, Creatinine | 1 | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | 1 |
| JMM | Column Chromatography & Color Development, Hydroxyproline | 1 | 1 |
Review panels
- Hematology (7)
- Clinical Chemistry (4)
Most recent Metrika, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051321 | INVIEW | LCP | 2005-06-13 | 24 |
| K033847 | A1CNOW FOR HOME AND PROFESSIONAL USE | LCP | 2003-12-23 | 12 |
| K022661 | A1CNOW FOR HOME USE | LCP | 2002-12-13 | 126 |
| K020235 | A1CNOW FOR PROFESSIONAL USE | LCP | 2002-02-15 | 23 |
| K020234 | A1CNOW FOR RX HOME USE | LCP | 2002-02-15 | 23 |
| K000885 | DRX HBA1C - FOR PRESCRIPTION HOME USE | LCP | 2000-09-26 | 190 |
| K000887 | DRX HBA1C | LCP | 2000-07-26 | 128 |
| K992997 | OSTEOMARK NTX POC | JMM | 1999-11-09 | 63 |
| K991532 | DRX QT. HCG | DHA | 1999-09-17 | 137 |
| K984530 | DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE | JFY | 1999-08-10 | 232 |
1 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-08-31.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Metrika, Inc. have?
Metrika, Inc. has 11 FDA 510(k) clearances (first 1999, latest 2005), across 5 product codes in 2 review panels.
How long does FDA take to clear Metrika, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Metrika, Inc.'s cleared 510(k)s is 63 days.
What devices does Metrika, Inc. make?
Its most frequent FDA product codes are LCP (Assay, Glycosylated Hemoglobin, 7); DHA (System, Test, Human Chorionic Gonadotropin, 1); JFY (Enzymatic Method, Creatinine, 1).
Has Metrika, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Metrika, Inc; the most recent began 2007-08-31. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 11 Metrika, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LCP, Metrika, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.