Cleared Abbreviated

K122177 - ELITECH CLINICAL SYSTEMS URINE TOTAL PR...

K122177 is the FDA 510(k) clearance for ELITECH CLINICAL SYSTEMS URINE TOTAL PR... by Elitechgroup. It is a Class 2 Chemistry device (product code JIT) cleared through the Abbreviated 510(k) pathway after a 207-day FDA review.

K122177 · Elitechgroup · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
207d
Days
Class 2
Risk

K122177 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH.... Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on February 15, 2013 after a review of 207 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Elitechgroup devices

Submission Details

510(k) Number K122177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2012
Decision Date February 15, 2013
Days to Decision 207 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 88d · This submission: 207d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIT Calibrator, Secondary

All 151
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K122177.
Elecsys Estradiol III CalSet
K142021 · Roche Diagnostics · Aug 2014
CA 125 II CALSET II
K140112 · Roche Diagnostics · Jun 2014
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
K130698 · Siemens Healthcare Diagnostics · Apr 2013
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
K113373 · Siemens Healthcare Diagnostics, Inc. · Dec 2011
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
K111952 · Beckman Coulter, Inc. · Aug 2011
ABBOTT ARCHITECT LH CALIBRATORS
K111023 · Abbott Laboratories · Jun 2011