Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 Controls

FDA 510(k) K141655 · Inova Diagnostics, Inc.

Substantially Equivalent

510(k) numberK141655

Submission

Device name
Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 Controls
Applicant
Inova Diagnostics, Inc.
San Diego, CA, US
Received
June 20, 2014
Decision date
March 5, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OBE – Anti-Ss-A 52 Autoantibodies
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5100
Specialty
Immunology

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, polymyositis and dermatomyositis.

Other 510(k)s with product code OBE

510(k)DeviceApplicantDecision
K250814Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBOBE · Traditional Zeus Scientific05/08/2026SE
K063565Quanta Lite Ss-A 52 ElisaOBE · Traditional Inova Diagnostics, Inc.04/04/2007SE

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Questions and answers

When was Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 Controls cleared by the FDA?

Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 Controls (K141655) received a 510(k) decision of Substantially Equivalent on March 5, 2015, 258 days after the submission was received.

What is the product code of K141655?

The FDA product code is OBE – Anti-Ss-A 52 Autoantibodies, a Class II (moderate risk) device regulated under 21 CFR 866.5100.