Cleared Traditional

K893896 - QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA

K893896 is an FDA 510(k) clearance for QUANTITATIVE ASSAY FOR DET. OF IGG IGM ..., manufactured by Biostar Medical Products, Inc.. The device is a Class 2 Immunology device with product code LKJ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K893896 · Biostar Medical Products, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1989
Decision
45d
Days
Class 2
Risk

K893896 is an FDA 510(k) clearance for the QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Biostar Medical Products, Inc. (Arlington, US). The FDA issued a Cleared decision on July 14, 1989 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.

View all Biostar Medical Products, Inc. devices

FDA 510(k) Submission Details - K893896

510(k) Number K893896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1989
Decision Date July 14, 1989
Days to Decision 45 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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 38
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K893896.
AUTOSTAT(TM) ANTI-DSNA
K913342 · Cogent Diagnotics , Ltd. · May 1992
DISTAT ANTI-SCL-70 KIT
K912291 · Shield Diagnostics, Ltd. · Jul 1991
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
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
K874115 · Sigma Diagnostics, Inc. · Nov 1987