Cleared Traditional

K934129 - STREP-A-CHEK

K934129 is an FDA 510(k) clearance for STREP-A-CHEK, manufactured by E-Y Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K934129 · E-Y Laboratories, Inc. · Microbiology device
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Aug 1994
Decision
379d
Days
Class 1
Risk

K934129 is an FDA 510(k) clearance for the STREP-A-CHEK. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by E-Y Laboratories, Inc. (San Mateo, US). The FDA issued a Cleared decision on August 26, 1994 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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. Elevated predicate reliance profile. 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 E-Y Laboratories, Inc. devices

FDA 510(k) Submission Details - K934129

510(k) Number K934129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1993
Decision Date August 26, 1994
Days to Decision 379 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
277d slower than avg
Panel avg: 102d · This submission: 379d
Pathway characteristics
Predicate-based equivalence.

JTO Device Classification - Class 1, General Controls

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 197
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K934129.
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DISPENS-O-DISC(TM) NITROCEFIN
K941016 · Difco Laboratories, Inc. · Jun 1994
BACTICARD STREP
K936021 · Remel Co. · May 1994
SERIM PYLORITEK REAGENT STRIPS
K936034 · Serim Research Corp. · Apr 1994