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510(k) K011082

TPO IGG ANTIBODY EIA TEST by Scimedx Corp. — Product Code JZO

K011082 is an FDA 510(k) premarket notification submitted by Scimedx Corp. for the device "TPO IGG ANTIBODY EIA TEST". The FDA issued a decision of Substantially Equivalent on June 6, 2001. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Scimedx Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2001
Date Received
April 10, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Thyroid Autoantibody
Device Class
Class II
Regulation Number
866.5870
Review Panel
IM
Submission Type

Other clearances by Scimedx Corp.

  • K011348 — PHASE II GBM IGG ANTIBODY EIA TEST (June 25, 2001)
  • K010625 — EUROSPITAL EU-TTG IGA UMANA (April 24, 2001)
  • K010287 — SCIMEDX PHASE II PR3 IGG ANTIBODY EIA (March 16, 2001)
  • K010289 — SCIMEDX PHASE II MPO IGG ANTIBODY EIA (March 7, 2001)
  • K002169 — GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM (October 19, 2000)
  • K002189 — GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM (October 19, 2000)
  • K002107 — IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CO (August 4, 2000)
  • K994379 — EU-TTG IGA ELISA (February 18, 2000)
  • K970198 — IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES (February 20, 1997)
  • K962360 — IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES (September 30, 1996)

Other clearances for product code JZO

  • K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II (October 17, 2025)
  • K240469 — Access TPO Antibody (August 9, 2024)
  • K213517 — Access Thyroglobulin Antibody II (September 26, 2023)
  • K222610 — Elecsys Anti-Tg (September 15, 2023)
  • K193313 — Elecsys Anti-TSHR (February 27, 2020)
  • K151799 — EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Contr (March 25, 2016)
  • K152061 — IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material (March 3, 2016)
  • K092229 — THYRETAIN TM TSI REPORTER BIOASSAY (May 18, 2010)
  • K090760 — THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-12 (September 3, 2009)
  • K083391 — THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY (May 21, 2009)

FDA data resources