Cleared Traditional

K001015 - ELECSYS THYROGLOBULIN CALCHECK

K001015 is the FDA 510(k) clearance for ELECSYS THYROGLOBULIN CALCHECK by Roche Diagnostics Corp.. It is a Class 1 Immunology device (product code JJX) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K001015 · Roche Diagnostics Corp. · Immunology device
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Apr 2000
Decision
29d
Days
Class 1
Risk

K001015 is an FDA 510(k) clearance for the ELECSYS THYROGLOBULIN 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 April 27, 2000 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology device 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 K001015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2000
Decision Date April 27, 2000
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 104d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

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 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 K001015.
ELECSYS INSULIN CALCHECK
K001846 · Roche Diagnostics Corp. · Jun 2000
SYNCHRON CONTROL
K001458 · Beckman Coulter, Inc. · Jun 2000
ELECSYS ANTI-TPO CALCHECK
K001014 · Roche Diagnostics Corp. · Jun 2000
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
K992781 · Bio-Rad · Apr 2000
ELECSYS B-CROSSLAPS CALCHECK
K000042 · Roche Diagnostics Corp. · Mar 2000
ACCESS HYBRITECH PSA QC, MODEL 37209
K994200 · Beckman Coulter, Inc. · Jan 2000