Cleared Traditional

K940588 - ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT

K940588 is an FDA 510(k) clearance for ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY..., manufactured by Helix Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LKO cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K940588 · Helix Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
71d
Days
Class 2
Risk

K940588 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT. Classified as Anti-rnp Antibody, Antigen And Control (product code LKO), Class II - Special Controls.

Submitted by Helix Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on April 20, 1994 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 Helix Diagnostics, Inc. devices

FDA 510(k) Submission Details - K940588

510(k) Number K940588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1994
Decision Date April 20, 1994
Days to Decision 71 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
34d faster than avg
Panel avg: 105d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKO Device Classification - Class 2, Special Controls

Product Code LKO Anti-rnp 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 - LKO Anti-rnp Antibody, Antigen And Control

All 16
Devices cleared under the same product code (LKO) and FDA review panel - the closest regulatory comparables to K940588.
THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K983465 · Zeus Scientific, Inc. · Nov 1998
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
K954831 · Orgentec · May 1996
HYTEC AUTOIMMUNE KITS (RNP)
K954897 · Hycor Biomedical, Inc. · Mar 1996
SYNELISA U1-SNRNP (68KDA)-ANTIBODIES
K930142 · Elias U.S.A., Inc. · May 1993
IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST
K911849 · General Biometrics, Inc. · May 1991
IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST
K911850 · General Biometrics, Inc. · May 1991