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
K140455Substantially Equivalent

Captia Measles Igm

Trinity Biotech USA, Jamestown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140455 is the FDA 510(k) clearance record for CAPTIA MEASLES IGM, a class I device, cleared for Trinity Biotech USA on under FDA product code PCL (Enzyme Linked Immunoabsorbent Assay, Rubeola Igm). FDA's definition for product code PCL reads: "The qualitative detection of measles specific IgM antibodies in serum or plasma". FDA records list 25 510(k) clearances for Trinity Biotech USA, from to . As of , FDA records show 2 recalls naming K140455.

Clearance record

Decision date
Received
(87 days to decision)
Product code
PCL Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Regulation
21 CFR 866.3520
Device class
Class I
Review panel
Microbiology
Applicant
Trinity Biotech USA 2823 Girts Rd., Jamestown NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PCL

Trailing 12 months

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

FDA records show no clearances under product code PCL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PCL, 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