Cleared Traditional

K802299 - K/K (ASMA/ANA) UNIVERSAL BIOPAK

K802299 is the FDA 510(k) clearance for K/K (ASMA/ANA) UNIVERSAL BIOPAK by Bioware Products. It is a Class 2 Immunology device (product code DHN) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K802299 · Bioware Products · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1981
Decision
132d
Days
Class 2
Risk

K802299 is an FDA 510(k) clearance for the K/K (ASMA/ANA) UNIVERSAL BIOPAK. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Bioware Products (Mchenry, US). The FDA issued a Cleared decision on January 29, 1981 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 Bioware Products devices

Submission Details

510(k) Number K802299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1980
Decision Date January 29, 1981
Days to Decision 132 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 104d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

All 59
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K802299.
ANA HEP-2 FLUORO-KIT
K822397 · Clinical Sciences, Inc. · Sep 1982
QUANTAFLUOR FLUORESCENT TEST REAGENTS
K813592 · Kallestad Laboratories, Inc. · Jan 1982
CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST
K810301 · Immuno Concepts, Inc. · Feb 1981
ANA-IFA TEST SYSTEM
K803276 · Immuno Concepts, Inc. · Jan 1981
ANATON
K801046 · Armkel, LLC · May 1980
LAB-TEK ANA TEST KIT
K792184 · Miles Laboratories, Inc. · Nov 1979