Cleared Traditional

K904099 - URIC ACID/IRON/MAGNESIUM LINEARITY STAN...

K904099 is the FDA 510(k) clearance for URIC ACID/IRON/MAGNESIUM LINEARITY STAN... by Hichem Diagnostics. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K904099 · Hichem Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
50d
Days
Class 1
Risk

K904099 is an FDA 510(k) clearance for the URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS. 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 October 26, 1990 after a review of 50 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hichem Diagnostics devices

Submission Details

510(k) Number K904099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date October 26, 1990
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 472
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K904099.
QCLYTE PROTEIN BASED ISE CONTROL
K904968 · Baxter Healthcare Corp · Dec 1990
KODATROL I AND II CONTROL AND DILUENT SET
K904768 · Eastman Kodak Company · Nov 1990
TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III
K904141 · Medical Analysis Systems, Inc. · Nov 1990
HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)
K904293 · Hichem Diagnostics · Oct 1990
DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2
K903933 · Baxter Healthcare Corp · Oct 1990
DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III
K903566 · Baxter Healthcare Corp · Sep 1990