510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141655Substantially Equivalent

Quanta Flash Ro52, Quanta Flash Ro52 Calibrators, and Quanta Flash Ro52 Controls

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

K141655 is the FDA 510(k) clearance record for QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS, a class II device, cleared for Inova Diagnostics, Inc. on under FDA product code OBE (Anti-Ss-A 52 Autoantibodies). FDA's definition for product code OBE reads: "The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis...". FDA records list 138 510(k) clearances for Inova Diagnostics, Inc., from to . As of , FDA records show no recalls naming K141655.

Clearance record

Decision date
Received
(258 days to decision)
Product code
OBE Anti-Ss-A 52 Autoantibodies
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Inova Diagnostics, Inc. 9900 Old Grove Rd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBE

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