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510(k) K021648

QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA by Inova Diagnostics, Inc. — Product Code NJF

K021648 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA". The FDA issued a decision of Substantially Equivalent on September 20, 2002. The device falls under product code NJF (Antibodies, Anti-Actin, Anti-Smooth Muscle), a Class II device regulated under 21 CFR 866.5120. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2002
Date Received
May 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibodies, Anti-Actin, Anti-Smooth Muscle
Device Class
Class II
Regulation Number
866.5120
Review Panel
IM
Submission Type

The device is used for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum as an aid in the diagnosis of certain autoimmune liver diseases, e.g. autoimmune hepatitis.

Other clearances by Inova Diagnostics, Inc.

  • K243979 — Aptiva APS IgA Reagent (February 6, 2026)
  • K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (December 17, 2024)
  • K213403 — Aptiva CTD Essential Reagent (September 29, 2023)
  • K200230 — Aptiva Celiac Disease IgG Reagent (August 26, 2021)
  • K193604 — Aptiva Celiac Disease IgA Reagent (June 16, 2021)
  • K192916 — NOVA Lite DAPI dsDNA Crithidia luciliae Kit (December 11, 2020)
  • K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents (April 17, 2019)
  • K180971 — QUANTA Flash Calprotectin and Fecal Extraction Device (October 16, 2018)
  • K180975 — QUANTA Flash HMGCR Reagents (June 25, 2018)
  • K170993 — QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANT (December 22, 2017)

FDA data resources