Cleared Traditional

K001846 - ELECSYS INSULIN CALCHECK

K001846 is the FDA 510(k) clearance for ELECSYS INSULIN CALCHECK by Roche Diagnostics Corp.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K001846 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
9d
Days
Class 1
Risk

K001846 is an FDA 510(k) clearance for the ELECSYS INSULIN CALCHECK. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 28, 2000 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K001846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2000
Decision Date June 28, 2000
Days to Decision 9 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 88d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Tuv Product Service, Inc.
CAROLE STAMP

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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 268
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K001846.
ELECSYS DHEA-S CALCHECK
K003772 · Roche Diagnostics Corp. · Dec 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
K003112 · Ortho-Clinical Diagnostics, Inc. · Nov 2000
SUGAR CHEX ONE
K001443 · Streck Laboratories, Inc. · Jun 2000
SYNCHRON CONTROL
K001458 · Beckman Coulter, Inc. · Jun 2000
ELECSYS ANTI-TPO CALCHECK
K001014 · Roche Diagnostics Corp. · Jun 2000
ELECSYS THYROGLOBULIN CALCHECK
K001015 · Roche Diagnostics Corp. · Apr 2000