510(k) · Cleared
ClearedSealite Sciences, Inc. Aqualite Prolactin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sealite Sciences, Inc. · CFT Radioimmunoassay, Prolactin (Lactogen)
Cleared on Feb 20, 1997 after a 34-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 20, 1997
- Review
- 34 days
- Class
- Class I
- Product code
- CFT
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CFT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Chiron Diagnostics ACS 180 Prolactin assay Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All CFT devicesCFT Radioimmunoassay, Prolactin (Lactogen): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFT
FDA has decided no CFT device since 2007.
Median 510(k) review, days · CFT
Too few CFT 510(k)s in any year since 2007 to give a median.
Recalls per year · CFT
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFT
23in 2025
MAUDE reports naming product code CFT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 1 | 27 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 0 | — | 0 | 29 |
| 2023 | 0 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 23 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AquaLite® Prolactin Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® Prolactin assay) is intended to be used in clinical laboratories for the quantitative determination of human prolactin levels in sera and plasma. The AquaLite® Prolactin assay is for in vitro diagnostic use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970188: Sealite Sciences, Inc. Aqualite Prolactin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970188
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026