Cleared Traditional

K980883 - N-ASSAY GLU-UL

K980883 is an FDA 510(k) clearance for N-ASSAY GLU-UL, manufactured by Crestat Diagnostics, Inc.. The device is a Class 2 Chemistry device with 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)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K980883

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
Combination Product No
PCCP Authorized No
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.

CFR Device Classification - Class 2, Special Controls

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 136
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K980883.
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
K000102 · Teco Diagnostics · Feb 2000
GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02
K990981 · A.P. Total Care, Inc. · May 1999
INFINITY GLUCOSE REAGENT
K984574 · Sigma Diagnostics, Inc. · Feb 1999
GLU
K981185 · Abbott Laboratories · May 1998
GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K980026 · Trace America, Inc. · Mar 1998
GLUCOSE REAGENT
K970664 · Derma Media Lab., Inc. · Aug 1997