Cleared Traditional

K923079 - IL TEST CALIBRATION SET APO A1B

K923079 is an FDA 510(k) clearance for IL TEST CALIBRATION SET APO A1B, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Immunology device with product code DFC cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K923079 · Instrumentation Laboratory CO · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
225d
Days
Class 2
Risk

K923079 is an FDA 510(k) clearance for the IL TEST CALIBRATION SET APO A1B. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on February 5, 1993 after a review of 225 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K923079

510(k) Number K923079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1992
Decision Date February 05, 1993
Days to Decision 225 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
120d slower than avg
Panel avg: 105d · This submission: 225d
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 K923079.
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