Cleared Special

K001679 - VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3

K001679 is an FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS AST SLIDE AND..., manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CIT cleared through the Special 510(k) pathway after a 27-day FDA review.

K001679 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
27d
Days
Class 2
Risk

K001679 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on June 28, 2000 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K001679

510(k) Number K001679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2000
Decision Date June 28, 2000
Days to Decision 27 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 89d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

CIT Device Classification - Class 2, Special Controls

Product Code CIT Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 137
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K001679.
AST (SGOT)
K013698 · Jas Diagnostics, Inc. · Dec 2001
WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.
K013145 · Wiener Laboratories Saic · Nov 2001
ATAC PAK AST REAGENT KIT
K010488 · Elan Holdings, Inc. · Apr 2001
WAKO L-TYPE GOT TEST
K993468 · Wako Chemicals USA, Inc. · Dec 1999
BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
K992136 · Bayer Corp. · Nov 1999
SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5
K992801 · Sigma Diagnostics, Inc. · Sep 1999
K001679 · VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
Download PDF FDA Summary Ortho-Clinical Diagno…