Cleared Traditional

K013145 - WIENER LAB. GOT (AST) UV AA. WEINER LAB...

K013145 is an FDA 510(k) clearance for WIENER LAB. GOT (AST) UV AA. WEINER LAB..., manufactured by Wiener Laboratories Saic. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K013145 · Wiener Laboratories Saic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
68d
Days
Class 2
Risk

K013145 is an FDA 510(k) clearance for the WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20.... Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on November 27, 2001 after a review of 68 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wiener Laboratories Saic devices

FDA 510(k) Submission Details - K013145

510(k) Number K013145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2001
Decision Date November 27, 2001
Days to Decision 68 days
Submission Type Traditional
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
20d faster than avg
Panel avg: 88d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 116
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K013145.
ACTIVATED ASPARTATE AMINOTRANSFERASE
K071525 · Abbott Laboratories · Mar 2008
COBAS C 111 ANALYZER
K071211 · Roche Diagnostics · Jul 2007
WIENER LAB GOT (AST) UV AA LIQUIDA
K023551 · Wiener Laboratories Saic · Dec 2002
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
K001679 · Ortho-Clinical Diagnostics, Inc. · Jun 2000
WAKO L-TYPE GOT TEST
K993468 · Wako Chemicals USA, Inc. · Dec 1999
BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
K992136 · Bayer Corp. · Nov 1999