Cleared Traditional

K971170 - CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)

K971170 is an FDA 510(k) clearance for CAMBRIDGE BIOTECH HUMAN LYME IGM WESTER..., manufactured by Cambridge Biotech Corp.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K971170 · Cambridge Biotech Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
326d
Days
Class 2
Risk

K971170 is an FDA 510(k) clearance for the CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112). Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Cambridge Biotech Corp. (Rockville, US). The FDA issued a Cleared decision on February 17, 1998 after a review of 326 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Cambridge Biotech Corp. devices

FDA 510(k) Submission Details - K971170

510(k) Number K971170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1997
Decision Date February 17, 1998
Days to Decision 326 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
224d slower than avg
Panel avg: 102d · This submission: 326d
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 K971170.
LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)
K970761 · Cambridge Diagnostics Ireland, Ltd. · Apr 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
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
K974809 · Boston Biomedica, Inc. · Feb 1998
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
K974810 · Boston Biomedica, Inc. · Feb 1998
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
K965129 · Wampole Laboratories · Mar 1997