Cleared Traditional

K954723 - ENZYME IMMUNOASSAY ANA SCREENING TEST KIT

K954723 is an FDA 510(k) clearance for ENZYME IMMUNOASSAY ANA SCREENING TEST KIT, manufactured by Helix Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LKJ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K954723 · Helix Diagnostics, Inc. · Immunology device
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Dec 1995
Decision
63d
Days
Class 2
Risk

K954723 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY ANA SCREENING TEST KIT. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Helix Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on December 15, 1995 after a review of 63 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 Helix Diagnostics, Inc. devices

FDA 510(k) Submission Details - K954723

510(k) Number K954723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1995
Decision Date December 15, 1995
Days to Decision 63 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 105d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKJ Device Classification - Class 2, Special Controls

Product Code LKJ Antinuclear Antibody, 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 - LKJ Antinuclear Antibody, Antigen, Control

All 37
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K954723.
QUALITROL ANA CONTROL SERUM SET
K961815 · Consolidated Technologies, Inc. · Sep 1996
HYTEC AUTOIMMUNE KIT (SS-A)
K954392 · Hycor Biomedical, Inc. · Dec 1995
HYTEC AUTOIMMUNE KITS (SS-B)
K954891 · Hycor Biomedical, Inc. · Dec 1995
DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT
K932876 · Shield Diagnostics, Ltd. · Nov 1993
SYNELISA CENP-B ANTIBODIES
K931255 · Elias U.S.A., Inc. · Sep 1993
SYLNELISA HISTONE ANTIBODIES
K932302 · Elias U.S.A., Inc. · Aug 1993