Cleared Traditional

K974811 - ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL

K974811 is an FDA 510(k) clearance for ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL, manufactured by Boston Biomedica, Inc.. The device is a Class 1 Microbiology device with product code JJX cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K974811 · Boston Biomedica, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
49d
Days
Class 1
Risk

K974811 is an FDA 510(k) clearance for the ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Boston Biomedica, Inc. (West Bridgewater, US). The FDA issued a Cleared decision on February 10, 1998 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - 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 - K974811

510(k) Number K974811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1997
Decision Date February 10, 1998
Days to Decision 49 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
53d faster than avg
Panel avg: 102d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 426
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K974811.
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