Cleared Traditional

K921132 - SYN ELISA DSDNA ANTIBODIES

K921132 is an FDA 510(k) clearance for SYN ELISA DSDNA ANTIBODIES, manufactured by Elias U.S.A., Inc.. The device is a Class 2 Immunology device with product code LKJ cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K921132 · Elias U.S.A., Inc. · Immunology device
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Dec 1992
Decision
266d
Days
Class 2
Risk

K921132 is an FDA 510(k) clearance for the SYN ELISA DSDNA ANTIBODIES. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on December 1, 1992 after a review of 266 days - an extended review 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: 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.

View all Elias U.S.A., Inc. devices

FDA 510(k) Submission Details - K921132

510(k) Number K921132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1992
Decision Date December 01, 1992
Days to Decision 266 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
161d slower than avg
Panel avg: 105d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKJ Device Classification - Class 2, Special Controls

Product Code LKJ Antinuclear Antibody, Antigen, 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 - LKJ Antinuclear Antibody, Antigen, Control

All 36
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K921132.
DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT
K932876 · Shield Diagnostics, Ltd. · Nov 1993
SYNELISA CENP-B ANTIBODIES
K931255 · Elias U.S.A., Inc. · Sep 1993
SYLNELISA HISTONE ANTIBODIES
K932302 · Elias U.S.A., Inc. · Aug 1993
THE THERATEST EL-ANA PROFILES
K914454 · Theratest Laboratories, Inc. · May 1992
AUTOSTAT(TM) ANTI-DSNA
K913342 · Cogent Diagnotics , Ltd. · May 1992
DISTAT ANTI-SCL-70 KIT
K912291 · Shield Diagnostics, Ltd. · Jul 1991