Cleared Traditional

K924945 - ELISA-DPXA SSA KIT

K924945 is an FDA 510(k) clearance for ELISA-DPXA SSA KIT, 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.

K924945 · Advanced Biological Products, Inc. · Immunology device
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May 1993
Decision
231d
Days
Class 2
Risk

K924945 is an FDA 510(k) clearance for the ELISA-DPXA SSA KIT. 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.

FDA 510(k) Submission Details - K924945

510(k) Number K924945 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
Combination Product No
PCCP Authorized No
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 181
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K924945.
ENCORE ENA COMBINED EIA
K931543 · Clark Laboratories, Inc. · Sep 1993
ANTI-SS-B/LA ANTIBODY TEST
K932419 · Helix Diagnostics, Inc. · Aug 1993
ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
K931495 · Helix Diagnostics, Inc. · Jul 1993
ELISA-DOXA SSB
K924946 · Advanced Biological Products, Inc. · May 1993
ELISA-DOXA SM
K924947 · Advanced Biological Products, Inc. · May 1993
ELISA-DOXA SM/RNP
K924948 · Advanced Biological Products, Inc. · May 1993
K924945 · ELISA-DPXA SSA KIT
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