Alere Scarborough, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Alere Scarborough, Inc.” (first 2012, latest 2019), plus 1 De Novo decision, across 9 product codes in 3 review panels. Median 510(k) review time under this name: 50 days. Since 2017 the median was 42 days, against 104 days for all cleared 510(k)s in the same product codes. 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 | 1 | 27 |
| 2013 | 0 | — |
| 2014 | 2 | 318 |
| 2015 | 3 | 57 |
| 2016 | 3 | 31 |
| 2017 | 3 | 105 |
| 2018 | 3 | 31 |
| 2019 | 1 | 42 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Alere Scarborough, Inc. took a median 42 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 5 | 5 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 3 | 3 |
| MYI | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies | 2 | 2 |
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | 2 |
| JBF | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | 1 | 1 |
| OAM | Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | 1 | 1 |
| OOI | Real Time Nucleic Acid Amplification System | 1 | 1 |
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | 1 | 1 |
| QFA | Assay For Detection Of Proteases In Chronic Wounds | 1 | 0 |
Review panels
- Microbiology (14)
- Clinical Chemistry (2)
- Hematology (1)
Most recent Alere Scarborough, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190204 | ID NOW Influenza A & B 2 | OZE | 2019-03-18 | 42 |
| K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader | PSZ | 2018-08-08 | 28 |
| K173653 | Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit | PGX | 2018-05-02 | 155 |
| K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | OCC | 2018-01-26 | 31 |
| K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | PSZ | 2017-12-13 | 30 |
| K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | OCC | 2017-09-29 | 105 |
| K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit | PSZ | 2017-04-10 | 200 |
| K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument | OCC | 2016-12-21 | 30 |
| K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit | OCC | 2016-08-18 | 92 |
| K161364 | BinaxNOW G6PD Test | JBF | 2016-06-17 | 31 |
6 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180014 | De Novo | Assay For Detection Of Proteases In Chronic Wounds | 2019-12-02 |
Recalls
openFDA lists no recalls under a recalling firm named Alere Scarborough, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Alere Scarborough, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Alere Scarborough, Inc D/B/A Binax, Inc. (4 510(k)s)
- Alere Technologies AS (3 510(k)s)
- Alere San Diego, Inc. (2 510(k)s)
- Alere, San Diego, Dba Biosite INcorporated, Dba IN (1 510(k)s)
- Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen (1 510(k)s)
- Alere San Diego, Inc (Formally Biosite Incorporate (1 510(k)s)
- Alere, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alere Scarborough, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Alere Scarborough, Inc.” (first 2012, latest 2019), plus 1 De Novo decision, across 9 product codes in 3 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 Alere Scarborough, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alere Scarborough, Inc. is 50 days. Since 2017: 42 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Alere Scarborough, Inc.?
The most frequent FDA product codes under this applicant name are OCC (Respiratory Virus Panel Nucleic Acid Assay System, 5); PSZ (Devices Detecting Influenza A, B, And C Virus Antigens, 3); MYI (System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies, 2).
Next steps
- See all 16 Alere Scarborough, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCC, Alere Scarborough, Inc.'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.