Cleared Traditional

K013492 - IMUBIND TPA ELISA

K013492 is the FDA 510(k) clearance for IMUBIND TPA ELISA by American Diagnostica, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K013492 · American Diagnostica, Inc. · Hematology device
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Mar 2002
Decision
142d
Days
Class 2
Risk

K013492 is an FDA 510(k) clearance for the IMUBIND TPA ELISA, MODEL 860. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by American Diagnostica, Inc. (Greenwich, US). The FDA issued a Cleared decision on March 13, 2002 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Diagnostica, Inc. devices

Submission Details

510(k) Number K013492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2001
Decision Date March 13, 2002
Days to Decision 142 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 113d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 Hematology devices follow this clearance model.

Regulatory Peers - GGP Test, Qualitative And Quantitative Factor Deficiency

All 127
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K013492.
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IL TEST FREE PROTEIN S
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COALIZA PROTEIN S-FREE
K002467 · Instrumentation Laboratory CO · Oct 2000