Cleared Traditional

K160370 - BS-800M/ ABS800/BA-800M ISE KIT

K160370 is the FDA 510(k) clearance for BS-800M/ ABS800/BA-800M ISE KIT by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K160370 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Chemistry device
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Jun 2016
Decision
120d
Days
Class 2
Risk

K160370 is an FDA 510(k) clearance for the BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistr.... Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 9, 2016 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 K160370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2016
Decision Date June 09, 2016
Days to Decision 120 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
32d slower than avg
Panel avg: 88d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 - JGS Electrode, Ion Specific, Sodium

All 111
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K160370.
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K161954 · Siemens Healthcare Diagnostics · Mar 2017
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer
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K160225 · Instrumentation Laboratory CO · Dec 2016
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
K151767 · Siemens Healthcare Diagnostics, Inc. · Dec 2015
ISE INDIRECT NA, K, C1 FOR GEN 2
K140373 · Roche Diagnostics · May 2014
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
K132418 · Roche Diagnostics · Dec 2013