Cleared Traditional

K112377 - BS-400 CHEMISTRY ANALYZER

K112377 is the FDA 510(k) clearance for BS-400 CHEMISTRY ANALYZER by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K112377 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Chemistry device
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Mar 2012
Decision
219d
Days
Class 2
Risk

K112377 is an FDA 510(k) clearance for the BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on March 23, 2012 after a review of 219 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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number K112377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2011
Decision Date March 23, 2012
Days to Decision 219 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
131d slower than avg
Panel avg: 88d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 100
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K112377.
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K170316 · Abbott Laboratories · Oct 2017
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
K131189 · Beckman Coulter, Inc. · Apr 2014
ADVIA CHEMISTRY GLUH_3 REAGENTS
K120681 · Siemens Healthcare Diagnostics, Inc. · May 2012
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
K101854 · Siemens Healthcare Diagnostics · Mar 2011
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
K092603 · Roche Diagnostics · Dec 2009
EASYRA GLU-H REAGENT, MODEL 10200
K092506 · Medica Corp. · Sep 2009