Cleared Traditional

K911803 - HI CHEM AQUEOUS MULTIANALYTE LINE STAND

K911803 is the FDA 510(k) clearance for HI CHEM AQUEOUS MULTIANALYTE LINE STAND by Hichem Diagnostics. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K911803 · Hichem Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
22d
Days
Class 1
Risk

K911803 is an FDA 510(k) clearance for the HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED. 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 May 15, 1991 after a review of 22 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 K911803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1991
Decision Date May 15, 1991
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
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 K911803.
ANEMIA I, II
K911984 · Ciba Corning Diagnostics Corp. · Jun 1991
DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL
K911854 · Baxter Healthcare Corp · Jun 1991
CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE
K911755 · Bionostics, Inc. · May 1991
DOCUMENT REFLECTANCE II LINEARITY TEST SET
K910440 · Casco Standards · May 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I
K911169 · Analytical Control Systems, Inc. · May 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III
K911171 · Analytical Control Systems, Inc. · May 1991