Cleared Traditional

K970302 - APO-TEK LP(A)

K970302 is an FDA 510(k) clearance for APO-TEK LP(A), manufactured by Perimmune, Inc.. The device is a Class 2 Immunology device with product code DFC cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K970302 · Perimmune, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K970302

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 105d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFC Device Classification - Class 2, Special Controls

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 37
Devices cleared under the same product code (DFC) and FDA review panel - the closest regulatory comparables to K970302.
WAKO AUTOKIT LP(A)
K981446 · Wako Chemicals USA, Inc. · Mar 1999
APOB
K983281 · Abbott Laboratories · Jan 1999
IMX HOMOCYSTEINE
K980812 · Axis Biochemicals, Asa · Oct 1998
WAKO AUTOKIT APO B
K954657 · Wako Chemicals USA, Inc. · Dec 1995
IL TEST CALIBRATION SET APO A1B
K923079 · Instrumentation Laboratory CO · Feb 1993
EQUATE(TM) AQR APO AL/B DUO CONTROL
K903122 · Binax, Inc. · Aug 1990