Cleared Traditional

K980883 - N-ASSAY GLU-UL

K980883 is the FDA 510(k) clearance for N-ASSAY GLU-UL by Crestat Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K980883 · Crestat Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Sep 1998
Decision
178d
Days
Class 2
Risk

K980883 is an FDA 510(k) clearance for the N-ASSAY GLU-UL. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Crestat Diagnostics, Inc. (Seattle, US). The FDA issued a Cleared decision on September 3, 1998 after a review of 178 days - an extended review 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: 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 Crestat Diagnostics, Inc. devices

Submission Details

510(k) Number K980883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1998
Decision Date September 03, 1998
Days to Decision 178 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 88d · This submission: 178d
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 108
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K980883.
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
K001403 · Sigma Diagnostics, Inc. · Aug 2000
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
K000102 · Teco Diagnostics · Feb 2000
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K984574 · Sigma Diagnostics, Inc. · Feb 1999
GLU
K981185 · Abbott Laboratories · May 1998
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K971754 · Pointe Scientific, Inc., · Jul 1997
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
K971276 · Bayer Corp. · Jun 1997