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
K090755Substantially Equivalent

Quanta Lite Aps/pt Igg and Igm Elisa

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

K090755 is the FDA 510(k) clearance record for QUANTA LITE APS/PT IGG AND IGM ELISA, a class II device, cleared for Inova Diagnostics, Inc. on under FDA product code OPN (Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex). FDA's definition for product code OPN reads: "For the detection of autoantibodies to phosphatidylserine (PS), prothrombin (PT), or phosphatidylserine/prothrombin (PS/PT) complex in human serum or plasma. To aid in the diagnosis of certain autoimmune thrombotic disorders such as...". FDA records list 138 510(k) clearances for Inova Diagnostics, Inc., from to . As of , FDA records show no recalls naming K090755.

Clearance record

Decision date
Received
(318 days to decision)
Product code
OPN Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Inova Diagnostics, Inc. 9900 Old Grove Rd., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code OPN

Trailing 12 months

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

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