Cleared Traditional

K974572 - GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820

K974572 is an FDA 510(k) clearance for GEN-PROBE ACCUPROBE GROUP B STREPTOCOCC..., manufactured by Chugai Pharmaceuticals Co., Ltd.. The device is a Class 1 Microbiology device with product code MDK cleared through the Traditional 510(k) pathway after a 293-day FDA review.

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

FDA 510(k) Submission Details - K974572

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 102d · This submission: 293d
Pathway characteristics
Predicate-based equivalence.

MDK Device Classification - Class 1, General Controls

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.