Biosite Incorporated: FDA filings under this applicant name
FDA lists 45 510(k) clearances under the applicant name “Biosite Incorporated” (first 1990, latest 2010), plus 1 De Novo decision, across 20 product codes in 4 review panels. Median 510(k) review time under this name: 74 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Abbott, based on public ownership records.
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 |
|---|---|---|---|
| NBC | Test, Natriuretic Peptide | 9 | 8 |
| DKZ | Enzyme Immunoassay, Amphetamine | 7 | 7 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 6 | 6 |
| DIF | Drug Mixture Control Materials | 4 | 4 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 2 | 2 |
| DJR | Enzyme Immunoassay, Methadone | 2 | 2 |
| GGN | Plasma, Coagulation Control | 2 | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 | 2 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 | 1 |
Plus 10 more product codes.
Review panels
- Clinical Chemistry (20)
- Clinical Toxicology (17)
- Hematology (7)
- Microbiology (2)
Most recent Biosite Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092987 | INRATIO/INRATIO2 TEST STRIPS | GJS | 2010-06-11 | 256 |
| K092048 | ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP | DJR | 2010-04-19 | 286 |
| K093032 | TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET | JJY | 2009-11-13 | 45 |
| K080269 | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS | NBC | 2008-06-06 | 126 |
| K072892 | TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 | JJY | 2007-12-07 | 58 |
| K062840 | TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS | GGN | 2007-03-01 | 160 |
| K062530 | TRIAGE PROTEIN C TEST | GGP | 2007-01-29 | 153 |
| K060788 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 | DIF | 2006-07-10 | 109 |
| K060791 | TRIAGE TOX DRUG SCREEN, MODEL 94400 | DJR | 2006-06-22 | 91 |
| K052789 | TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 | NBC | 2006-01-23 | 112 |
35 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN000010 | De Novo | Test, Natriuretic Peptide | 2000-11-20 |
Recalls
11 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2009-04-27.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biosite Incorporated?
FDA lists 45 510(k) clearances under the applicant name “Biosite Incorporated” (first 1990, latest 2010), plus 1 De Novo decision, across 20 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biosite Incorporated?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biosite Incorporated is 74 days.
Which FDA product codes appear under Biosite Incorporated?
The most frequent FDA product codes under this applicant name are NBC (Test, Natriuretic Peptide, 9); DKZ (Enzyme Immunoassay, Amphetamine, 7); JJY (Multi-Analyte Controls, All Kinds (Assayed), 6).
Next steps
- See all 45 Biosite Incorporated clearances with predicates and recalls
- Run predicate analysis for product code NBC, Biosite Incorporated's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.