Cleared Traditional

K932419 - ANTI-SS-B/LA ANTIBODY TEST

K932419 is an FDA 510(k) clearance for ANTI-SS-B/LA ANTIBODY TEST, 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 79-day FDA review.

K932419 · Helix Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
79d
Days
Class 2
Risk

K932419 is an FDA 510(k) clearance for the ANTI-SS-B/LA ANTIBODY TEST. 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 August 5, 1993 after a review of 79 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.

FDA 510(k) Submission Details - K932419

510(k) Number K932419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1993
Decision Date August 05, 1993
Days to Decision 79 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 105d · This submission: 79d
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 K932419.
DIASTAT ANTI-CENTROMERE KIT
K932877 · Shield Diagnostics, Ltd. · Oct 1993
ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN
K932850 · Helix Diagnostics, Inc. · Sep 1993
ENCORE ENA COMBINED EIA
K931543 · Clark Laboratories, Inc. · Sep 1993
ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
K931495 · Helix Diagnostics, Inc. · Jul 1993
ELISA-DPXA SSA KIT
K924945 · Advanced Biological Products, Inc. · May 1993
ELISA-DOXA SSB
K924946 · Advanced Biological Products, Inc. · May 1993
K932419 · ANTI-SS-B/LA ANTIBODY TEST
Download PDF FDA Summary Helix Diagnostics, In…