Spectral Diagnostics, Inc.: FDA clearances and approvals
Spectral Diagnostics, Inc. has 11 FDA 510(k) clearances (first 1997, latest 2006), plus 1 De Novo decision, across 8 product codes in 3 review panels. Median 510(k) review time: 60 days.
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 |
|---|---|---|---|
| MMI | Immunoassay Method, Troponin Subunit | 4 | 4 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 | 1 |
| JHT | Chromatographic Separation, Cpk Isoenzymes | 1 | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| NGS | Assay, Endotoxin Activity, Chemiluminescent | 1 | 0 |
| NOP | Elisa, Antibody, West Nile Virus | 1 | 1 |
Review panels
- Clinical Chemistry (9)
- Microbiology (2)
- Immunology (1)
Most recent Spectral Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052519 | SPECTRAL WEST NILE VIRUS IGM STATUS TEST | NOP | 2006-11-30 | 442 |
| K030057 | SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST | MMI | 2003-03-19 | 71 |
| K022409 | SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST | JHT | 2002-09-30 | 68 |
| K020950 | SPECTRAL'S 2 IN 1 (TNI-MYO) | MMI | 2002-05-24 | 60 |
| K014105 | SPECTRAL'S TROPONIN I | MMI | 2002-02-01 | 50 |
| K992127 | CARDIOQUANT TROPONIN I TEST | MMI | 1999-10-04 | 103 |
| K991447 | CARDIOQUANT CARDIAC ASSESSMENT CONTROLS | JJY | 1999-06-11 | 46 |
| K982679 | MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST | DDR | 1998-10-07 | 68 |
| K981474 | CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) | JJY | 1998-05-07 | 13 |
| K972687 | CARDIAC STATUS CONTROLS/TROPONIN I | JJX | 1997-07-28 | 11 |
1 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN030002 | De Novo | Assay, Endotoxin Activity, Chemiluminescent | 2003-06-16 |
Recalls
openFDA lists no recalls under a recalling firm named Spectral Diagnostics, Inc..
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 Spectral Diagnostics, Inc. have?
Spectral Diagnostics, Inc. has 11 FDA 510(k) clearances (first 1997, latest 2006), plus 1 De Novo decision, across 8 product codes in 3 review panels.
How long does FDA take to clear Spectral Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Spectral Diagnostics, Inc.'s cleared 510(k)s is 60 days.
What devices does Spectral Diagnostics, Inc. make?
Its most frequent FDA product codes are MMI (Immunoassay Method, Troponin Subunit, 4); JJY (Multi-Analyte Controls, All Kinds (Assayed), 2); DDR (Myoglobin, Antigen, Antiserum, Control, 1).
Has Spectral Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Spectral Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 11 Spectral Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MMI, Spectral Diagnostics, 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.