Cleared Traditional

K881379 - WESBLOT RNP-SM TEST

K881379 is an FDA 510(k) clearance for WESBLOT RNP-SM TEST, manufactured by American Bionetics, Inc.. The device is a Class 2 Immunology device with product code LKP cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K881379 · American Bionetics, Inc. · Immunology device
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May 1988
Decision
45d
Days
Class 2
Risk

K881379 is an FDA 510(k) clearance for the WESBLOT RNP-SM TEST. Classified as Anti-sm Antibody, Antigen And Control (product code LKP), Class II - Special Controls.

Submitted by American Bionetics, Inc. (Hayward, US). The FDA issued a Cleared decision on May 16, 1988 after a review of 45 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 - K881379

510(k) Number K881379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1988
Decision Date May 16, 1988
Days to Decision 45 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 105d · This submission: 45d
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 27
Devices cleared under the same product code (LKP) and FDA review panel - the closest regulatory comparables to K881379.
DIASTAT ANTI-SM
K905191 · Shield Diagnostics, Ltd. · Dec 1990
DIASTAT ANTI-SM/RNP
K905192 · Shield Diagnostics, Ltd. · Dec 1990
RHEUMELISA ASSAY FOR SM AUTOANTIBODIES
K895996 · Lipogen, Inc. · Nov 1989
SM ANTIBODY TEST KIT
K880254 · Lipogen, Inc. · Apr 1988
IMMUSTRIP(TM) SM ELISA TEST SYSTEM
K873741 · Immunomedics, Inc. · Nov 1987
ENZYMATIC ACETAMINOPHEN ASSAY
K841930 · Diagnostic Chemicals, Ltd. (Usa) · Jun 1984
K881379 · WESBLOT RNP-SM TEST
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