Cleared Traditional

K911590 - IMMUNOWELL BORRELIA (LYME)TEST

K911590 is an FDA 510(k) clearance for IMMUNOWELL BORRELIA (LYME)TEST, manufactured by General Biometrics, Inc.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K911590 · General Biometrics, Inc. · Microbiology device
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Dec 1991
Decision
255d
Days
Class 2
Risk

K911590 is an FDA 510(k) clearance for the IMMUNOWELL BORRELIA (LYME)TEST. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 20, 1991 after a review of 255 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 General Biometrics, Inc. devices

FDA 510(k) Submission Details - K911590

510(k) Number K911590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1991
Decision Date December 20, 1991
Days to Decision 255 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 102d · This submission: 255d
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 63
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K911590.
BARTELS LYME DISEASE IGM EIA
K922578 · Baxter Diagnostics, Inc. · Sep 1992
IMMUNODOT BORRELIA (LYME) TEST
K911627 · General Biometrics, Inc. · Apr 1992
IMMUNOWELL LYME (P39 RECOMBINANT) TEST
K911599 · General Biometrics, Inc. · Dec 1991
LYME-CHECK(TM) TEST KIT
K896378 · Diagnostic Technology, Inc. · Nov 1991
LYME STAT M TEST KIT
K904652 · Whittaker Bioproducts, Inc. · Oct 1991
FIAX LYME M TEST KIT
K904893 · Whittaker Bioproducts, Inc. · Oct 1991