Cleared Traditional

K924947 - ELISA-DOXA SM

K924947 is an FDA 510(k) clearance for ELISA-DOXA SM, manufactured by Advanced Biological Products, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K924947 · Advanced Biological Products, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
231d
Days
Class 2
Risk

K924947 is an FDA 510(k) clearance for the ELISA-DOXA SM. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Advanced Biological Products, Inc. (Hatboro, US). The FDA issued a Cleared decision on May 19, 1993 after a review of 231 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 Advanced Biological Products, Inc. devices

FDA 510(k) Submission Details - K924947

510(k) Number K924947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1992
Decision Date May 19, 1993
Days to Decision 231 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 105d · This submission: 231d
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 148
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K924947.
RELISA ENA ANTIBODY SCREENING TEST SYSTEM
K935129 · Immuno Concepts, Inc. · Jan 1994
QUANTA LITE(TM) HISTONE ELISA
K934053 · Inova Diagnostics, Inc. · Dec 1993
DIASTAT ANTI-CENTROMERE KIT
K932877 · Shield Diagnostics, Ltd. · Oct 1993
SYNELISA JO-1 ANTIBODIES
K930281 · Elias U.S.A., Inc. · Apr 1993
SYNELISA SCL-70 ANTIBODIES
K930417 · Elias U.S.A., Inc. · Apr 1993
QUANTA LITE(TM) JO-1 ELISA KIT
K926562 · Inova Diagnostics, Inc. · Mar 1993