Cleared Traditional

K972048 - ACCURUN 117 HBEAG POSITIVE CONTROL

K972048 is an FDA 510(k) clearance for ACCURUN 117 HBEAG 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 71-day FDA review.

K972048 · Boston Biomedica, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
71d
Days
Class 1
Risk

K972048 is an FDA 510(k) clearance for the ACCURUN 117 HBEAG 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 71 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 - K972048

510(k) Number K972048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1997
Decision Date August 12, 1997
Days to Decision 71 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
31d faster than avg
Panel avg: 102d · This submission: 71d
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
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K972048.
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)
K973030 · Johnson & Johnson Clinical Diagnostics, Inc. · Sep 1997
TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
K972868 · Bionostics, Inc. · Aug 1997
ACCURUN 121 HAV IGM POSITIVE CONTROL
K971657 · Boston Biomedica, Inc. · Aug 1997
PRECICONTROL TUMOR MARKER 1 AND 2
K972235 · Boehringer Mannheim Corp. · Aug 1997
ACCURUN 120 HAV IGG POSITIVE CONTROL
K971406 · Boston Biomedica, Inc. · Aug 1997
ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL
K972307 · Boston Biomedica, Inc. · Aug 1997