Cleared Traditional

LYME ELISA TEST SYSTEM (K885317) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K885317 · Zeus Scientific, Inc. · Microbiology device
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Mar 1989
Decision
62d
Days
Class 2
Risk

K885317 is an FDA 510(k) clearance for the LYME ELISA TEST SYSTEM. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on March 2, 1989 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zeus Scientific, Inc. devices

Submission Details

510(k) Number K885317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1988
Decision Date March 02, 1989
Days to Decision 62 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
40d faster than avg
Panel avg: 102d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K885317.
3M IGG FASTLYME(TM) TEST
K895713 · 3M Company · Dec 1990
LYME IGM ELISA TEST SYSTEM
K900196 · Zeus Scientific, Inc. · May 1990
LYME IGG ELISA TEST SYSTEM
K895292 · Zeus Scientific, Inc. · Dec 1989
LYME FAST TEST
K883544 · 3M Company · Jan 1989
IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI
K871246 · Zeus Scientific, Inc. · Aug 1987