Cleared Traditional

K843150 - SYSTEMATE GLUCOSE 67216

K843150 is the FDA 510(k) clearance for SYSTEMATE GLUCOSE 67216 by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K843150 · Em Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
17d
Days
Class 2
Risk

K843150 is an FDA 510(k) clearance for the SYSTEMATE GLUCOSE 67216. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 27, 1984 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K843150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1984
Decision Date August 27, 1984
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFR Hexokinase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CFR Hexokinase, Glucose

All 107
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K843150.
GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS
K853826 · Catachem, Inc. · Sep 1985
GLUCOSE SR LIQUID STABLE REAGENT SET
K853464 · Medical Analysis Systems, Inc. · Sep 1985
PDA GLUCOSE
K843541 · Abbott Laboratories · Sep 1984
GLUCOSE ASSAY KIT-HEXOKINASE
K842510 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984
SIGMA PROCEDURE 16-UV
K841555 · Sigma Chemical Co. · May 1984
HEXOKINASE, GLUCOSE
K832872 · Pointe Scientific, Inc., · Oct 1983