Cleared Traditional

K974810 - ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL

K974810 is an FDA 510(k) clearance for ACCURUN(TM) 132 BORRELIA BURDORFERI IGM..., manufactured by Boston Biomedica, Inc.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K974810 · Boston Biomedica, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
44d
Days
Class 2
Risk

K974810 is an FDA 510(k) clearance for the ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Boston Biomedica, Inc. (West Bridgewater, US). The FDA issued a Cleared decision on February 5, 1998 after a review of 44 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 Boston Biomedica, Inc. devices

FDA 510(k) Submission Details - K974810

510(k) Number K974810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1997
Decision Date February 05, 1998
Days to Decision 44 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
58d faster than avg
Panel avg: 102d · This submission: 44d
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 K974810.
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K971170 · Cambridge Biotech Corp. · Feb 1998
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
K974809 · Boston Biomedica, Inc. · Feb 1998
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K965131 · Wampole Laboratories · Mar 1997
VIDAS LYME SCREEN II
K943812 · Biomerieux Vitek, Inc. · Jun 1995