Cleared Traditional

GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 (K974572) - FDA 510(k) Clearance

Class I Microbiology device.

K974572 · Chugai Pharmaceuticals Co., Ltd. · Microbiology device
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Sep 1998
Decision
293d
Days
Class 1
Risk

K974572 is an FDA 510(k) clearance for the GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820. Classified as Dna-probe, Reagents, Streptococcal (product code MDK), Class I - General Controls.

Submitted by Chugai Pharmaceuticals Co., Ltd. (San Diego, US). The FDA issued a Cleared decision on September 24, 1998 after a review of 293 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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 Chugai Pharmaceuticals Co., Ltd. devices

Submission Details

510(k) Number K974572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1997
Decision Date September 24, 1998
Days to Decision 293 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 102d · This submission: 293d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDK Dna-probe, Reagents, Streptococcal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
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.