Cleared Traditional

K013492 - IMUBIND TPA ELISA, MODEL 860

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

K013492 · American Diagnostica, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K013492

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
Combination Product No
PCCP Authorized No
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.

GGP Device Classification - Class 2, Special Controls

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 189
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K013492.
MODIFICATION TO COATEST FACTOR VIII
K033631 · Instrumentation Laboratory CO · Dec 2003
CHROMOCHECK PROTEIN C 25
K023990 · Precision Biologic · Mar 2003
PROTEIN S AC
K022290 · Dade Behring, Inc. · Aug 2002
IMUBIND PLASMA PAI-1 ELISA,MODEL 822
K013168 · American Diagnostica, Inc. · Mar 2002
ACTICLOT PROTEIN S, MODEL 843L
K012386 · American Diagnostica, Inc. · Sep 2001
IL TEST PROS
K011424 · Instrumentation Laboratory CO · Jun 2001
K013492 · IMUBIND TPA ELISA, MODEL 860
Download PDF FDA Summary American Diagnostica,…