Cleared Traditional

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

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

K802299 · Bioware Products · Immunology device
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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

FDA 510(k) Submission Details - K802299

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
27d slower than avg
Panel avg: 105d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHN Device Classification - Class 2, Special Controls

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 72
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