Cleared Traditional

LIGHT DIAGNOSTICS RABIES DFA REAGENT (K972975) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K972975 · Light Diagnostics · Microbiology device
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Dec 1998
Decision
498d
Days
Class 2
Risk

K972975 is an FDA 510(k) clearance for the LIGHT DIAGNOSTICS RABIES DFA REAGENT. Classified as Antiserum, Fluorescent, Rabies Virus (product code GOI), Class II - Special Controls.

Submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on December 22, 1998 after a review of 498 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3460 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Light Diagnostics devices

Submission Details

510(k) Number K972975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1997
Decision Date December 22, 1998
Days to Decision 498 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
396d slower than avg
Panel avg: 102d · This submission: 498d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GOI Antiserum, Fluorescent, Rabies Virus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3460
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 Microbiology devices follow this clearance model.