Cleared Traditional

K884266 - PH BLOOD GAS CONTROL PRODUCTS

K884266 is the FDA 510(k) clearance for PH BLOOD GAS CONTROL PRODUCTS by Alko Diagnostic Corp.. It is a Class 2 Chemistry device (product code JPK) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K884266 · Alko Diagnostic Corp. · Chemistry device
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May 1989
Decision
217d
Days
Class 2
Risk

K884266 is an FDA 510(k) clearance for the PH BLOOD GAS CONTROL PRODUCTS. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on May 16, 1989 after a review of 217 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.8625 - 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 Alko Diagnostic Corp. devices

Submission Details

510(k) Number K884266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1988
Decision Date May 16, 1989
Days to Decision 217 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 88d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - JPK Mixture, Hematology Quality Control

All 134
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K884266.
QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE
K904637 · R&D Systems, Inc. · Oct 1990
CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED
K904464 · R&D Systems, Inc. · Oct 1990
REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)
K900017 · Helena Laboratories · Jan 1990
NE-CHECK
K890767 · Streck Laboratories, Inc. · Mar 1989
CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE
K890749 · R&D Systems, Inc. · Feb 1989
MSI-DIFF PLUS
K880270 · Medical Specialties, Inc. · Mar 1988