Cleared Traditional

K971657 - ACCURUN 121 HAV IGM POSITIVE CONTROL

K971657 is an FDA 510(k) clearance for ACCURUN 121 HAV IGM POSITIVE CONTROL, manufactured by Boston Biomedica, Inc.. The device is a Class 1 Microbiology device with product code JJY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K971657 · Boston Biomedica, Inc. · Microbiology device
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Aug 1997
Decision
98d
Days
Class 1
Risk

K971657 is an FDA 510(k) clearance for the ACCURUN 121 HAV IGM 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 12, 1997 after a review of 98 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

FDA 510(k) Submission Details - K971657

510(k) Number K971657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1997
Decision Date August 12, 1997
Days to Decision 98 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
4d faster than avg
Panel avg: 102d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

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)

All 572
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