Cleared Traditional

K970761 - LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)

K970761 is an FDA 510(k) clearance for LIMITED HUMAN LYME IGG WESTERN BLOT KIT..., manufactured by Cambridge Diagnostics Ireland, Ltd.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 402-day FDA review.

K970761 · Cambridge Diagnostics Ireland, Ltd. · Microbiology device
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Apr 1998
Decision
402d
Days
Class 2
Risk

K970761 is an FDA 510(k) clearance for the LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND). Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Cambridge Diagnostics Ireland, Ltd. (Galway, IE). The FDA issued a Cleared decision on April 9, 1998 after a review of 402 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Cambridge Diagnostics Ireland, Ltd. devices

FDA 510(k) Submission Details - K970761

510(k) Number K970761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1997
Decision Date April 09, 1998
Days to Decision 402 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
300d slower than avg
Panel avg: 102d · This submission: 402d
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
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K970761.
IS BORRELIA BURGDORFERI IGM TEST SYSTEM
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K971006 · Mrl Diagnostics · Jun 1998
LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)
K971007 · Mrl Diagnostics · Jun 1998
HUMAN LYME IGM WESTERN BLOT KIT
K970768 · Cambridge Diagnostics Ireland, Ltd. · Apr 1998
CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)
K971169 · Cambridge Biotech Corp. · Feb 1998
CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)
K971170 · Cambridge Biotech Corp. · Feb 1998