Cleared Traditional

K873708 - FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES

K873708 is an FDA 510(k) clearance for FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES, manufactured by Whittaker Bioproducts, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K873708 · Whittaker Bioproducts, Inc. · Immunology device
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Nov 1987
Decision
71d
Days
Class 2
Risk

K873708 is an FDA 510(k) clearance for the FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on November 25, 1987 after a review of 71 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Whittaker Bioproducts, Inc. devices

FDA 510(k) Submission Details - K873708

510(k) Number K873708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1987
Decision Date November 25, 1987
Days to Decision 71 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 105d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear Antibody, Antigen And 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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 147
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K873708.
NOVA GEL(TM) SM/RNP
K881181 · Inova Diagnostics, Inc. · Apr 1988
NOVA LITE(TM) ANA
K880736 · Inova Diagnostics, Inc. · Mar 1988
NOVA GEL(TM) SS-A/SS-B
K880896 · Inova Diagnostics, Inc. · Mar 1988
ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)
K871994 · Behring Diagnostics, Inc. · Aug 1987
SERATEST ENA [SS-B] KIT
K862700 · Hemagen Diagnostics, Inc. · Aug 1986
KALLESTAD SSA/SSB ENA TEST REAGENTS
K862710 · Kallestad Laboratories, Inc. · Jul 1986