Cleared Traditional

K904613 - TRICHINELLA SEROLOGY MICROTITER ELISA

K904613 is an FDA 510(k) clearance for TRICHINELLA SEROLOGY MICROTITER ELISA, manufactured by Lmd Laboratories. The device is a Class 1 Microbiology device with product code GPG cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K904613 · Lmd Laboratories · Microbiology device
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Mar 1991
Decision
161d
Days
Class 1
Risk

K904613 is an FDA 510(k) clearance for the TRICHINELLA SEROLOGY MICROTITER ELISA. Classified as Antigen, Latex Agglutination, Trichinella Spiralis (product code GPG), Class I - General Controls.

Submitted by Lmd Laboratories (San Diego, US). The FDA issued a Cleared decision on March 21, 1991 after a review of 161 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3850 - 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.

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FDA 510(k) Submission Details - K904613

510(k) Number K904613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1990
Decision Date March 21, 1991
Days to Decision 161 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 102d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

GPG Device Classification - Class 1, General Controls

Product Code GPG Antigen, Latex Agglutination, Trichinella Spiralis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3850
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.