Cleared Traditional

K013168 - IMUBIND PLASMA PAI-1 ELISA,MODEL 822

K013168 is an FDA 510(k) clearance for IMUBIND PLASMA PAI-1 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 167-day FDA review.

K013168 · American Diagnostica, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
167d
Days
Class 2
Risk

K013168 is an FDA 510(k) clearance for the IMUBIND PLASMA PAI-1 ELISA,MODEL 822. 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 7, 2002 after a review of 167 days - an extended review cycle.

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

FDA 510(k) Submission Details - K013168

510(k) Number K013168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2001
Decision Date March 07, 2002
Days to Decision 167 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
54d slower than avg
Panel avg: 113d · This submission: 167d
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.

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All 158
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