Cleared Traditional

ACCURUN 120 HAV IGG POSITIVE CONTROL (K971406) - FDA 510(k) Clearance

Class I Microbiology device.

K971406 · Boston Biomedica, Inc. · Microbiology device
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Aug 1997
Decision
113d
Days
Class 1
Risk

K971406 is an FDA 510(k) clearance for the ACCURUN 120 HAV IGG POSITIVE CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Boston Biomedica, Inc. (West Bridgewater, US). The FDA issued a Cleared decision on August 7, 1997 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Boston Biomedica, Inc. devices

Submission Details

510(k) Number K971406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1997
Decision Date August 07, 1997
Days to Decision 113 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 102d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

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