Home / 510(k) Clearances / K142595

510(k) K142595

VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II by Ortho Clinical Diagnostics — Product Code PDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2015
Date Received
September 15, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin A1c Test System
Device Class
Class II
Regulation Number
862.1373
Review Panel
CH
Submission Type

Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.

Other clearances by Ortho Clinical Diagnostics

  • K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack (August 28, 2024)
  • K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (May 8, 2024)
  • K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (September 5, 2023)
  • K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack (August 23, 2023)
  • K231525 — VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (August 9, 2023)
  • K221355 — VITROS Immuodiagnostic Products CA 125 II Reagent Pack (December 12, 2022)
  • K213626 — VITROS AFP (June 15, 2022)
  • K212648 — VITROS Immunodiagnostic Products CK-MB Reagent Pack (January 28, 2022)
  • K201312 — VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack (October 4, 2021)
  • K200236 — VITROS BRAHMS PCT Reagent Pack and Calibrators (February 25, 2020)

Other clearances for product code PDJ

  • K252749 — Medconn 8K Glycated Hemoglobin Test System (January 6, 2026)
  • K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (October 3, 2025)
  • K242911 — Medconn Glycated Hemoglobin Test system (June 20, 2025)
  • K220999 — Hipro Glycosylated Hemoglobin (HbA1c) Test System (September 12, 2024)
  • K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (August 5, 2021)
  • K200256 — ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (July 2, 2021)
  • K193053 — Tina-quant Hemoglobin A1cDx Gen.3 (March 26, 2020)
  • K182651 — HbA1c Advanced (January 16, 2019)
  • K182988 — Afinion HbA1c Dx on Afinion 2 (November 29, 2018)
  • K173909 — Dimension Hemoglobin A1c Assay (July 13, 2018)