510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K001525Substantially Equivalent

Captia Syphilis-G Elisa Test System

Trinity Biotech, PLC, Jamestown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001525 is the FDA 510(k) clearance record for CAPTIA SYPHILIS-G ELISA TEST SYSTEM, a class II device, cleared for Trinity Biotech, Plc on under FDA product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum). FDA records list 12 510(k) clearances for Trinity Biotech, Plc, from to . As of , FDA records show no recalls naming K001525.

Clearance record

Decision date
Received
(197 days to decision)
Product code
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Applicant
Trinity Biotech, Plc P.O. Box 1059, 2823 Girts Rd., Jamestown NY
510(k) summary
Summary
Third party review
No

Clearances, product code LIP

Trailing 12 months

FDA records hold no clearances under product code LIP in the trailing twelve months.

FDA records show no clearances under product code LIP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260