Cleared Traditional

K112538 - ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT

K112538 is an FDA 510(k) clearance for ACE CHOLESTEROL REAGENT, manufactured by Alfa Wassermann Diagnostic Technologies, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K112538 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
210d
Days
Class 1
Risk

K112538 is an FDA 510(k) clearance for the ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERI.... Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on March 29, 2012 after a review of 210 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Alfa Wassermann Diagnostic Technologies, Inc. devices

FDA 510(k) Submission Details - K112538

510(k) Number K112538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2011
Decision Date March 29, 2012
Days to Decision 210 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
122d slower than avg
Panel avg: 88d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CHH Enzymatic Esterase--oxidase, Cholesterol

All 186
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K112538.
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
K122757 · Alfa Wassermann Diagnostic Technologies, Inc. · Oct 2012
EON CHOLESTEROL REAGENT
K120202 · Vital Diagnostics Pty., Ltd. · Jul 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT
K113262 · Alfa Wassermann Diagnostic Technologies, Inc. · Jul 2012
HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE
K111753 · Hitachi Chemical Diagnostics, Inc. · Dec 2011
CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
K080623 · Jas Diagnostics, Inc. · Nov 2008
EASYRA CHOLESTEROL REAGENT
K072249 · Medica Corp. · Feb 2008