Cleared Traditional

K881438 - UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN

K881438 is an FDA 510(k) clearance for UREA/GLUCOSE/CREATININE SERUM RANGE LIN..., manufactured by Hichem Diagnostics. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K881438 · Hichem Diagnostics · Chemistry device
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Jul 1988
Decision
92d
Days
Class 1
Risk

K881438 is an FDA 510(k) clearance for the UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on July 6, 1988 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 - K881438

510(k) Number K881438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1988
Decision Date July 06, 1988
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 596
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K881438.
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II
K882542 · Bio-Rad · Jul 1988
MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL
K881503 · Baxter Healthcare Corp · Jul 1988
CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS
K881437 · Hichem Diagnostics · Jul 1988
CLP LIPOPROTEIN ELECTROPHORESIS CONTROL
K881113 · Creative Laboratory Products, Inc. · Jul 1988
SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS
K881436 · Hichem Diagnostics · Jun 1988
MULTI-FUNCTION BLOOD GAS CONTROL
K880447 · Bionostics, Inc. · May 1988