Cleared Traditional

APO-TEK LP(A) (K970302) - FDA 510(k) Clearance

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

K970302 · Perimmune, Inc. · Immunology device
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Nov 1997
Decision
287d
Days
Class 2
Risk

K970302 is an FDA 510(k) clearance for the APO-TEK LP(A). Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by Perimmune, Inc. (Rockville, US). The FDA issued a Cleared decision on November 10, 1997 after a review of 287 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5600 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Perimmune, Inc. devices

Submission Details

510(k) Number K970302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1997
Decision Date November 10, 1997
Days to Decision 287 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 104d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFC Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5600
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 Immunology devices follow this clearance model.

Regulatory Peers - DFC Lipoprotein, Low-density, Antigen, Antiserum, Control

All 41
Devices cleared under the same product code (DFC) and FDA review panel - the closest regulatory comparables to K970302.
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K013128 · Dade Behring, Inc. · Jan 2002
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K013206 · Roche Diagnostics Corp. · Nov 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013207 · Roche Diagnostics Corp. · Nov 2001