Cleared Abbreviated

K122177 - ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL

K122177 is an FDA 510(k) clearance for ELITECH CLINICAL SYSTEMS URINE TOTAL PR..., manufactured by Elitechgroup. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K122177

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 88d · This submission: 207d
Pathway characteristics
Standards-based clearance path.

JIT Device Classification - Class 2, Special Controls

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 210
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K122177.
PATHFAST CK-MB-II CALIBRATORS
K130628 · Mitsubishi Chemical Medience Corporation · Oct 2013
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
K131556 · Diazyme Laboratories · Jun 2013
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
K130698 · Siemens Healthcare Diagnostics · Apr 2013
DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
K121027 · Diamond Diagnostics, Inc. · Dec 2012
DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2
K120591 · Diamond Diagnostics, Inc. · Apr 2012
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
K113373 · Siemens Healthcare Diagnostics, Inc. · Dec 2011