Cleared Traditional

MUMPS IGG ELISA TESTY (K971857) - FDA 510(k) Clearance

Class I Microbiology device.

K971857 · Gull Laboratories, Inc. · Microbiology device
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Nov 1997
Decision
168d
Days
Class 1
Risk

K971857 is an FDA 510(k) clearance for the MUMPS IGG ELISA TESTY. Classified as Enzyme Linked Immunoabsorbent Assay, Mumps Virus (product code LJY), Class I - General Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 4, 1997 after a review of 168 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3380 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gull Laboratories, Inc. devices

Submission Details

510(k) Number K971857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1997
Decision Date November 04, 1997
Days to Decision 168 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 102d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3380
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.