Cleared Traditional

K061879 - SDI CA480 CLINICAL CHEMISTRY SYSTEM

Also marketed or referenced as:
SATURNO 300 CLINICAL CHEMISTRY SYSTEM

K061879 is an FDA 510(k) clearance for SDI CA480 CLINICAL CHEMISTRY SYSTEM, manufactured by Hemodiagnostica, LLC. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K061879 · Hemodiagnostica, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
165d
Days
Class 2
Risk

K061879 is an FDA 510(k) clearance for the SDI CA480 CLINICAL CHEMISTRY SYSTEM. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Hemodiagnostica, LLC (Johns Island, US). The FDA issued a Cleared decision on December 15, 2006 after a review of 165 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 Hemodiagnostica, LLC devices

FDA 510(k) Submission Details - K061879

510(k) Number K061879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2006
Decision Date December 15, 2006
Days to Decision 165 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
77d slower than avg
Panel avg: 88d · This submission: 165d
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 K061879.
S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU
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K072018 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2008
POINTE 360
K062118 · Pointe Scientific, Inc., · Jul 2007
GLUCOSE HK NEW FORMULATION TEST SYSTEM
K062239 · Roche Diagnostics Corp. · Sep 2006
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
K061048 · Roche Diagnostics Corp. · May 2006
GLUCOSE
K060383 · Abbott Laboratories · May 2006