Cleared Traditional

K972975 - LIGHT DIAGNOSTICS RABIES DFA REAGENT

K972975 is an FDA 510(k) clearance for LIGHT DIAGNOSTICS RABIES DFA REAGENT, manufactured by Light Diagnostics. The device is a Class 2 Microbiology device with product code GOI cleared through the Traditional 510(k) pathway after a 498-day FDA review.

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.

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FDA 510(k) Submission Details - K972975

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
Combination Product No
PCCP Authorized No
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.

GOI Device Classification - Class 2, Special Controls

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.