Cleared Traditional

K091216 - CLINITEK STATUS+ANALYZER AND CLINITEK S...

K091216 is an FDA 510(k) clearance for CLINITEK STATUS+ANALYZER AND CLINITEK S..., manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K091216 · Siemens Healthcare Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
165d
Days
Class 2
Risk

K091216 is an FDA 510(k) clearance for the CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Norowood, US). The FDA issued a Cleared decision on October 9, 2009 after a review of 165 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1340 - 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 Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K091216

510(k) Number K091216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2009
Decision Date October 09, 2009
Days to Decision 165 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
77d slower than avg
Panel avg: 88d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIL Device Classification - Class 2, Special Controls

Product Code JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1340
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 - JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)

All 37
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K091216.
URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
K131600 · Teco Diagnostics · May 2014
FORESIGHT U120 URINE ANALYZER
K120124 · ACON Laboratories, Inc. · Mar 2012
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
K101673 · Teco Diagnostics · Feb 2011
CLINITEK ADVANTUS, MODEL 1420
K063276 · Bayer Healthcare, LLC · Dec 2006
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
K032437 · Roche Diagnostics Corp. · Oct 2003
URS-IG (GLUCOSE TEST)
K020175 · Teco Diagnostics · Mar 2002