Cleared Traditional

K821461 - ULTRACHEM E-GLU

K821461 is the FDA 510(k) clearance for ULTRACHEM E-GLU by Emd Chemicals, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K821461 · Emd Chemicals, Inc. · Chemistry device
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Jun 1982
Decision
15d
Days
Class 2
Risk

K821461 is an FDA 510(k) clearance for the ULTRACHEM E-GLU, #64976 & 65040. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1982 after a review of 15 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 Emd Chemicals, Inc. devices

Submission Details

510(k) Number K821461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1982
Decision Date June 02, 1982
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
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 K821461.
HEXOKINASE, GLUCOSE
K832872 · Pointe Scientific, Inc., · Oct 1983
GLUCOSE HEXOKINASE DIAG. KIT
K831560 · Sclavo, Inc. · Jul 1983
ULTRACHEM E-GLU #64976&65040
K821475 · Emd Chemicals, Inc. · Jun 1982
ULTRACHEM E-GLU #64976 & 65040
K821470 · Emd Chemicals, Inc. · Jun 1982
ULTRA CHEM E-GLU #64976 & 65040
K812595 · Harleco · Sep 1981
GLUCOSE-HK SYSTEM PACK TEST
K812303 · Boehringer Mannheim Corp. · Sep 1981