Helena Laboratories: FDA clearances and approvals
Helena Laboratories has 282 FDA 510(k) clearances (first 1978, latest 2022), across 83 product codes in 4 review panels. Median 510(k) review time: 56 days. openFDA lists 16 product recalls by a recalling firm named Helena Laboratories.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 138 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 638 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Helena Laboratories's cleared 510(k)s took a median 638 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 193 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | 19 | 19 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 17 | 17 |
| CEF | Electrophoretic, Protein Fractionation | 15 | 15 |
| JHO | Electrophoretic Separation, Lipoproteins | 15 | 15 |
| KHE | Reagent, Occult Blood | 12 | 12 |
| CFE | Electrophoretic, Lactate Dehydrogenase Isoenzymes | 11 | 11 |
| JBD | System, Analysis, Electrophoretic Hemoglobin | 11 | 11 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 11 | 11 |
| JJN | Apparatus, Electrophoresis, For Clinical Use | 8 | 8 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 8 | 8 |
Plus 73 more product codes.
Review panels
- Hematology (136)
- Clinical Chemistry (120)
- Immunology (23)
- Pathology (3)
Most recent Helena Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213396 | SPIFE A1AT kit | OBZ | 2022-10-13 | 360 |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | GKA | 2022-04-19 | 915 |
| K131479 | V8 SP NORMAL CONTROL, ABNORMAL CONTROL | JJY | 2013-10-07 | 138 |
| K100103 | SPECIALTY ASSAYED CONTROL-2 | GGC | 2010-12-15 | 336 |
| K061991 | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA | GHR | 2007-02-23 | 225 |
| K061069 | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 | CFF | 2006-07-06 | 80 |
| K061014 | ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP | JPA | 2006-05-10 | 27 |
| K050053 | HEMORAM/AGGRAM ANALYZER | JPA | 2005-07-11 | 182 |
| K024162 | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 | CFF | 2003-02-19 | 64 |
| K023761 | PLATELETWORKS, MODELS PW-A, PW-C | JOZ | 2003-02-14 | 98 |
272 earlier clearances. See the full list in Caduvo.
Recalls
16 product recalls in 14 recall events; 2 initiated in the last five years. Most recent: 2023-05-02.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Helena Laboratories's product codes (a text match, not an official crosswalk):
- J7197 — Antithrombin iii (human), per i.u. (via JBQ)
- J1460 — Injection, gamma globulin, intramuscular, 1 cc (via DAH)
- J7213 — Injection, coagulation factor ix (recombinant), ixinity, 1 i.u. (via GJT)
- J1560 — Injection, gamma globulin, intramuscular, over 10 cc (via DAH)
Frequently asked questions
How many FDA 510(k) clearances does Helena Laboratories have?
Helena Laboratories has 282 FDA 510(k) clearances (first 1978, latest 2022), across 83 product codes in 4 review panels.
How long does FDA take to clear Helena Laboratories's 510(k)s?
The median time from FDA receipt to decision across Helena Laboratories's cleared 510(k)s is 56 days.
What devices does Helena Laboratories make?
Its most frequent FDA product codes are LCP (Assay, Glycosylated Hemoglobin, 19); GGP (Test, Qualitative And Quantitative Factor Deficiency, 17); CEF (Electrophoretic, Protein Fractionation, 15).
Has Helena Laboratories had device recalls?
openFDA lists 16 product recalls in 14 recall events by a recalling firm whose name matches Helena Laboratories; the most recent began 2023-05-02. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 282 Helena Laboratories clearances with predicates and recalls
- Run predicate analysis for product code LCP, Helena Laboratories'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.