Cleared Traditional

K220977 - ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220977 · Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jul 2023
Decision
472d
Days
Class 2
Risk

K220977 is an FDA 510(k) clearance for the ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on July 20, 2023 after a review of 472 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. devices

Submission Details

510(k) Number K220977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2022
Decision Date July 20, 2023
Days to Decision 472 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
384d slower than avg
Panel avg: 88d · This submission: 472d
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 161
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