Cleared Traditional

K931495 - ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT

K931495 is an FDA 510(k) clearance for ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBOD..., manufactured by Helix Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K931495 · Helix Diagnostics, Inc. · Immunology device
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Jul 1993
Decision
113d
Days
Class 2
Risk

K931495 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Helix Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on July 16, 1993 after a review of 113 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.

FDA 510(k) Submission Details - K931495

510(k) Number K931495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1993
Decision Date July 16, 1993
Days to Decision 113 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 105d · This submission: 113d
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 181
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K931495.
ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN
K932850 · Helix Diagnostics, Inc. · Sep 1993
ENCORE ENA COMBINED EIA
K931543 · Clark Laboratories, Inc. · Sep 1993
ANTI-SS-B/LA ANTIBODY TEST
K932419 · Helix Diagnostics, Inc. · Aug 1993
ELISA-DPXA SSA KIT
K924945 · Advanced Biological Products, Inc. · May 1993
ELISA-DOXA SSB
K924946 · Advanced Biological Products, Inc. · May 1993
ELISA-DOXA SM
K924947 · Advanced Biological Products, Inc. · May 1993
K931495 · ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
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