Cleared Traditional

K925553 - HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813

K925553 is an FDA 510(k) clearance for HI CHEM CO2 ALKALINE BUFFER REAGENT KIT, manufactured by Hichem Diagnostics. The device is a Class 2 Chemistry device with product code JFL cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K925553 · Hichem Diagnostics · Chemistry device
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Feb 1993
Decision
101d
Days
Class 2
Risk

K925553 is an FDA 510(k) clearance for the HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813. Classified as Ph Rate Measurement, Carbon-dioxide (product code JFL), Class II - Special Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - 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 Hichem Diagnostics devices

FDA 510(k) Submission Details - K925553

510(k) Number K925553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1992
Decision Date February 12, 1993
Days to Decision 101 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
13d slower than avg
Panel avg: 88d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFL Device Classification - Class 2, Special Controls

Product Code JFL Ph Rate Measurement, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JFL Ph Rate Measurement, Carbon-dioxide

All 22
Devices cleared under the same product code (JFL) and FDA review panel - the closest regulatory comparables to K925553.
SIGMA CO2 ACID REAGENT
K933692 · Sigma Chemical Co. · Dec 1993
SIGMA ELECTROLYTE BUFFER
K933695 · Sigma Chemical Co. · Oct 1993
HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812
K925552 · Hichem Diagnostics · Feb 1993
SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS
K897183 · Beckman Instruments, Inc. · Mar 1990
BICARBONATE REAGENTS PRODUCT #7713 & #7714
K900420 · American Research Products Co. · Mar 1990
REPLACEMENT PARTS NOVA ELECTROLYTE ANAL
K842656 · Shaban Mfg. Co. · Aug 1984