Cleared Traditional

K933588 - APHLELISA KIT

K933588 is an FDA 510(k) clearance for APHLELISA KIT, manufactured by Louisville Apl Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 444-day FDA review.

K933588 · Louisville Apl Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
444d
Days
Class 2
Risk

K933588 is an FDA 510(k) clearance for the APHLELISA KIT. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Louisville Apl Diagnostics, Inc. (Louisville, US). The FDA issued a Cleared decision on October 13, 1994 after a review of 444 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Louisville Apl Diagnostics, Inc. devices

FDA 510(k) Submission Details - K933588

510(k) Number K933588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1993
Decision Date October 13, 1994
Days to Decision 444 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
339d slower than avg
Panel avg: 105d · This submission: 444d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MID Device Classification - Class 2, Special Controls

Product Code MID System, Test, Anticardiolipin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - MID System, Test, Anticardiolipin Immunological

All 77
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K933588.
ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST)
K933784 · Immco Diagnostics, Inc. · Mar 1995
ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST
K933786 · Immco Diagnostics, Inc. · Mar 1995
ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST
K933788 · Immco Diagnostics, Inc. · Mar 1995
ELIAS CARDIOLIPIN ANTIBODIES
K940403 · Elias U.S.A., Inc. · Sep 1994
HEMAGEN ACL IGA CALIBRATOR
K941840 · Hemagen Diagnostics, Inc. · Jun 1994
SYNELISA CARDIOLIPIN ANTIBODIES
K935288 · Elias U.S.A., Inc. · Jan 1994