Cleared Traditional

K080468 - LIASYS WITH MODELS LIASYS

K080468 is an FDA 510(k) clearance for LIASYS WITH MODELS LIASYS, manufactured by Ams S.R.L. Analyzer Medical System. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K080468 · Ams S.R.L. Analyzer Medical System · Chemistry device
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Jul 2008
Decision
155d
Days
Class 2
Risk

K080468 is an FDA 510(k) clearance for the LIASYS WITH MODELS LIASYS. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Ams S.R.L. Analyzer Medical System (Guidonia, Rome, IT). The FDA issued a Cleared decision on July 25, 2008 after a review of 155 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 Ams S.R.L. Analyzer Medical System devices

FDA 510(k) Submission Details - K080468

510(k) Number K080468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2008
Decision Date July 25, 2008
Days to Decision 155 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 88d · This submission: 155d
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 133
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K080468.
POLY-CHEM 90 GLUCOSE
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K080123 · Wako Chemicals USA, Inc. · Jul 2008
S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU
K072140 · Alfa Wassermann Diagnostic Technologies, Inc. · Jun 2008
BS-200 CHEMISTRY ANALYZER, MODE BS-200
K072018 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2008