Home / 510(k) Clearances / K991532

510(k) K991532

DRX QT. HCG by Metrika, Inc. — Product Code DHA

K991532 is an FDA 510(k) premarket notification submitted by Metrika, Inc. for the device "DRX QT. HCG". The FDA issued a decision of Substantially Equivalent on September 17, 1999. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Metrika, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1999
Date Received
May 3, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Metrika, Inc.

  • K051321 — INVIEW (June 13, 2005)
  • K033847 — A1CNOW FOR HOME AND PROFESSIONAL USE (December 23, 2003)
  • K022661 — A1CNOW FOR HOME USE (December 13, 2002)
  • K020235 — A1CNOW FOR PROFESSIONAL USE (February 15, 2002)
  • K020234 — A1CNOW FOR RX HOME USE (February 15, 2002)
  • K000885 — DRX HBA1C - FOR PRESCRIPTION HOME USE (September 26, 2000)
  • K000887 — DRX HBA1C (July 26, 2000)
  • K992997 — OSTEOMARK NTX POC (November 9, 1999)
  • K984530 — DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE (August 10, 1999)
  • K991917 — OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET (July 12, 1999)

Other clearances for product code DHA

  • K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (May 8, 2024)
  • K223690 — iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (December 11, 2023)
  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)
  • K230790 — Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT (May 19, 2023)
  • K221990 — Access Total ßhCG (5th IS) (December 27, 2022)
  • K212221 — Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemilu (December 13, 2021)
  • K203227 — Elecsys HCG STAT (August 18, 2021)
  • K200210 — ADVIA Centaur® Total hCG assay (July 13, 2021)
  • K192547 — MAGLUMI 2000 HCG/ß-HCG (January 17, 2020)
  • K192790 — Atellica IM Total hCG (ThCG) (October 30, 2019)

FDA data resources