Cleared Traditional

K883767 - LYME DISEASE IFA (IGM)

K883767 is an FDA 510(k) clearance for LYME DISEASE IFA (IGM), manufactured by Hillcrest Biologicals. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K883767 · Hillcrest Biologicals · Microbiology device
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Mar 1989
Decision
190d
Days
Class 2
Risk

K883767 is an FDA 510(k) clearance for the LYME DISEASE IFA (IGM). Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on March 15, 1989 after a review of 190 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 Hillcrest Biologicals devices

FDA 510(k) Submission Details - K883767

510(k) Number K883767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1988
Decision Date March 15, 1989
Days to Decision 190 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
88d slower than avg
Panel avg: 102d · This submission: 190d
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 97
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K883767.
BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY
K885290 · Medical Diagnostic Technologies, Inc. · Apr 1989
BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM
K885293 · Medical Diagnostic Technologies, Inc. · Apr 1989
BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM
K885294 · Medical Diagnostic Technologies, Inc. · Apr 1989
LYME ELISA TEST SYSTEM
K885317 · Zeus Scientific, Inc. · Mar 1989
LYME FAST TEST
K883544 · 3M Company · Jan 1989
LYME DISEASE IFA (IGG)
K883487 · Hillcrest Biologicals · Dec 1988