Cleared Traditional

K993971 - MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM

K993971 is an FDA 510(k) clearance for MDI SS-B TEST ENZYME IMMUNOASSAY FOR TH..., manufactured by Micro Detect, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K993971 · Micro Detect, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
49d
Days
Class 2
Risk

K993971 is an FDA 510(k) clearance for the MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B .... Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Micro Detect, Inc. (Tustin, US). The FDA issued a Cleared decision on January 11, 2000 after a review of 49 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 - K993971

510(k) Number K993971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1999
Decision Date January 11, 2000
Days to Decision 49 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 105d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear 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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 179
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K993971.
RHIGENE MESACUP2 TEST- SSB
K000751 · Rhigene, Inc. · May 2000
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
K000489 · Helix Diagnostics, Inc. · Apr 2000
ENA PROFILE ELISA TEST SYSTEM
K993839 · Trinity Biotech USA · Jan 2000
MDI SM TEST
K994029 · Micro Detect, Inc. · Jan 2000
QUANTA LITE ANA ELISA
K991657 · Inova Diagnostics, Inc. · Jun 1999
AUTOSTAT II ANTI-SS-B/LA ELISA
K990626 · Cogent Diagnotics , Ltd. · Apr 1999
K993971 · MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM
Download PDF FDA Summary Micro Detect, Inc.