Cleared Traditional

K953366 - QUANTA LITE IGA ACA (HRP)

K953366 is the FDA 510(k) clearance for QUANTA LITE IGA ACA (HRP) by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code MID) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K953366 · Inova Diagnostics, Inc. · Immunology device
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Sep 1995
Decision
45d
Days
Class 2
Risk

K953366 is an FDA 510(k) clearance for the QUANTA LITE IGA ACA (HRP). Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on September 1, 1995 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K953366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1995
Decision Date September 01, 1995
Days to Decision 45 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
59d faster than avg
Panel avg: 104d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MID System, Test, Anticardiolipin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - MID System, Test, Anticardiolipin Immunological

All 45
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K953366.
ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
K970177 · Immco Diagnostics, Inc. · Jun 1997
HEMAGEN ANTI CARDIOLIPIN SCREEN
K971039 · Hemagen Diagnostics, Inc. · Jun 1997
VARELISA CARDIOLIPIN ABS SCREEN
K951187 · Elias U.S.A., Inc. · Oct 1995
QUANTA LITE ACA SCREEN (HRP)
K953291 · Inova Diagnostics, Inc. · Aug 1995
QUANTA LITE(TM) IGG (HRP)
K946034 · Inova Diagnostics, Inc. · Jul 1995
QUANTA LITE ACA IGM (HRP)
K946385 · Inova Diagnostics, Inc. · Jul 1995