Cleared Traditional

K940510 - ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT

K940510 is an FDA 510(k) clearance for ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TES..., manufactured by Helix Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LKP cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K940510 · Helix Diagnostics, Inc. · Immunology device
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Apr 1994
Decision
75d
Days
Class 2
Risk

K940510 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT. Classified as Anti-sm Antibody, Antigen And Control (product code LKP), 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 75 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 - K940510

510(k) Number K940510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1994
Decision Date April 20, 1994
Days to Decision 75 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
30d faster than avg
Panel avg: 105d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKP Device Classification - Class 2, Special Controls

Product Code LKP Anti-sm 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 - LKP Anti-sm Antibody, Antigen And Control

All 20
Devices cleared under the same product code (LKP) and FDA review panel - the closest regulatory comparables to K940510.
SERAQUEST ANTI-SM/RNP
K980811 · Quest Intl., Inc. · May 1998
ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY
K954830 · Orgentec · May 1996
HYTEC AUTOIMMUNE KITS (SM)
K954896 · Hycor Biomedical, Inc. · Mar 1996
SYNELISA SM ABS/RNP-SM ABS
K930141 · Elias U.S.A., Inc. · May 1993
IMMUNOWELL RNP/SM ANTIBODY TEST
K911848 · General Biometrics, Inc. · May 1991
IMMUNOWELL SM ANTIBODY TEST
K911851 · General Biometrics, Inc. · May 1991