Home / 510(k) Clearances / K070066

510(k) K070066

QUANTA LITE RNA POL III ELISA by Inova Diagnostics, Inc. — Product Code NYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2007
Date Received
January 8, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use.

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)

Other clearances for product code NYO

  • K202541 — EliA RNA Pol III (September 13, 2021)
  • K172078 — ImmuLisa Enhanced RNA POL III Antibody ELISA (March 30, 2018)
  • K060431 — ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 (June 19, 2006)