Cleared Traditional

K964985 - QUANTA LITE IGG GLIADIN ELISA

K964985 is an FDA 510(k) clearance for QUANTA LITE IGG GLIADIN ELISA, manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K964985 · Inova Diagnostics, Inc. · Immunology device
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May 1997
Decision
168d
Days
Class 2
Risk

K964985 is an FDA 510(k) clearance for the QUANTA LITE IGG GLIADIN ELISA. Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on May 30, 1997 after a review of 168 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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 Inova Diagnostics, Inc. devices

FDA 510(k) Submission Details - K964985

510(k) Number K964985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1996
Decision Date May 30, 1997
Days to Decision 168 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
63d slower than avg
Panel avg: 105d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MST Device Classification - Class 2, Special Controls

Product Code MST Antibodies, Gliadin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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.