Cleared Traditional

K921132 - SYN ELISA DSDNA ANTIBODIES

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

K921132 · Elias U.S.A., Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
162d slower than avg
Panel avg: 104d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 26
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K921132.
HYTEC AUTOIMMUNE KITS (SS-B)
K954891 · Hycor Biomedical, Inc. · Dec 1995
SYNELISA CENP-B ANTIBODIES
K931255 · Elias U.S.A., Inc. · Sep 1993
SYLNELISA HISTONE ANTIBODIES
K932302 · Elias U.S.A., Inc. · Aug 1993
SERATEST ENA [SCL-70] KIT
K894411 · Hemagen Diagnostics, Inc. · Aug 1989
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
K883883 · Immco Diagnostics, Inc. · Oct 1988
ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)
K883949 · Immco Diagnostics, Inc. · Oct 1988