Cleared Traditional

K991062 - QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024

K991062 is an FDA 510(k) clearance for QUALICODE B. BURGDORFERI IGM WESTERN BL..., manufactured by Immunetics, Inc.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K991062 · Immunetics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
174d
Days
Class 2
Risk

K991062 is an FDA 510(k) clearance for the QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Immunetics, Inc. (Cambridge,, US). The FDA issued a Cleared decision on September 21, 1999 after a review of 174 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - 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 Immunetics, Inc. devices

FDA 510(k) Submission Details - K991062

510(k) Number K991062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1999
Decision Date September 21, 1999
Days to Decision 174 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
72d slower than avg
Panel avg: 102d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSR Device Classification - Class 2, Special Controls

Product Code LSR Reagent, Borrelia Serological Reagent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
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.

Regulatory Peers - LSR Reagent, Borrelia Serological Reagent

All 83
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