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
K254295Substantially Equivalent

Sofia Lyme FIA; Sofia 2 Campylobacter FIA

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho), San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K254295 is the FDA 510(k) clearance record for Sofia Lyme FIA; Sofia 2 Campylobacter FIA, a class II device, cleared for Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) on under FDA product code LSR (Reagent, Borrelia Serological Reagent). FDA records list one 510(k) clearance for Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). As of , FDA records show no recalls naming K254295.

Clearance record

Decision date
Received
(191 days to decision)
Product code
LSR Reagent, Borrelia Serological Reagent
Regulation
21 CFR 866.3830
Device class
Class II
Review panel
Microbiology
Applicant
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) 9975 Summers Ridge Rd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LSR

Trailing 12 months
2 clearances under product code LSR in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LSR, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260