Cleared Traditional

ALBUMIN COBALT BINDING TEST (ACB TEST) (K023824) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023824 · Ischemia Technologies, Inc. · Chemistry device
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Feb 2003
Decision
88d
Days
Class 2
Risk

K023824 is an FDA 510(k) clearance for the ALBUMIN COBALT BINDING TEST (ACB TEST). Classified as Test, Albumin Cobalt Binding (product code NJV), Class II - Special Controls.

Submitted by Ischemia Technologies, Inc. (Denver, US). The FDA issued a Cleared decision on February 14, 2003 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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 Ischemia Technologies, Inc. devices

Submission Details

510(k) Number K023824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 18, 2002
Decision Date February 14, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NJV Test, Albumin Cobalt Binding
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
Definition The Albumin Cobalt Binding Test Is A Quantitative In Vitro Diagnostic Test Used On Human Serum That Detects Ischemia Modified Albumin By Measuring The Cobalt Binding Capacity Of Albumin In Human Serum. Ima Is Intended For Use In Conjunction With Other Tests Such As Ecg And Cardiac Troponin As An Aid To The Short Term Risk Stratification Of Patients Presenting With Chest Pain Suggestive Of Cardiac Origin.
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.