Cleared Traditional

K952178 - PH-DETECT TEST

K952178 is an FDA 510(k) clearance for PH-DETECT TEST, manufactured by Diagnostic Reagents, Inc.. The device is a Class 1 Chemistry device with product code JQY cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K952178 · Diagnostic Reagents, Inc. · Chemistry device
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Oct 1995
Decision
164d
Days
Class 1
Risk

K952178 is an FDA 510(k) clearance for the PH-DETECT TEST. Classified as Ph Meter (product code JQY), Class I - General Controls.

Submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 20, 1995 after a review of 164 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2050 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Reagents, Inc. devices

FDA 510(k) Submission Details - K952178

510(k) Number K952178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1995
Decision Date October 20, 1995
Days to Decision 164 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 88d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

JQY Device Classification - Class 1, General Controls

Product Code JQY Ph Meter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
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 - JQY Ph Meter

Devices cleared under the same product code (JQY) and FDA review panel - the closest regulatory comparables to K952178.
CIBA CORNING 288 PH/BLOOD GAS SYSTEM
K872888 · Ciba Corning Diagnostics Corp. · Aug 1987
METER, PH, DIGITAL, MODEL 3560
K770347 · Beckman Instruments, Inc. · Apr 1977
METER, IV PH, MODEL EXPANDOMATIC
K770352 · Beckman Instruments, Inc. · Apr 1977
METER, IV PH, MODEL ZEROMATIC
K770351 · Beckman Instruments, Inc. · Apr 1977
PH METER-125 (.01 PH)
K760788 · Corning Medical & Scientific · Nov 1976
PH METER-130 (.001 PH)
K760789 · Corning Medical & Scientific · Nov 1976