Cleared Traditional

K151487 - Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method

K151487 is an FDA 510(k) clearance for Diatron Pictus 700 Clinical Chemistry A..., manufactured by Diatron U.S., Inc.. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K151487 · Diatron U.S., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
226d
Days
Class 2
Risk

K151487 is an FDA 510(k) clearance for the Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose.... Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Diatron U.S., Inc. (Hialeah, US). The FDA issued a Cleared decision on January 14, 2016 after a review of 226 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 Diatron U.S., Inc. devices

FDA 510(k) Submission Details - K151487

510(k) Number K151487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2015
Decision Date January 14, 2016
Days to Decision 226 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
138d slower than avg
Panel avg: 88d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFR Device Classification - Class 2, Special Controls

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 Consultant

Ammirati Regulatory Consulting
Erika B Ammirati

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CFR Hexokinase, Glucose

All 136
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