Cleared Traditional

K001014 - ELECSYS ANTI-TPO CALCHECK

K001014 is the FDA 510(k) clearance for ELECSYS ANTI-TPO CALCHECK by Roche Diagnostics Corp.. It is a Class 1 Immunology device (product code JJX) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K001014 · Roche Diagnostics Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
64d
Days
Class 1
Risk

K001014 is an FDA 510(k) clearance for the ELECSYS ANTI-TPO 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 1, 2000 after a review of 64 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 K001014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2000
Decision Date June 01, 2000
Days to Decision 64 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
40d faster than avg
Panel avg: 104d · This submission: 64d
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 K001014.
SUGAR CHEX ONE
K001443 · Streck Laboratories, Inc. · Jun 2000
ELECSYS INSULIN CALCHECK
K001846 · Roche Diagnostics Corp. · Jun 2000
SYNCHRON CONTROL
K001458 · Beckman Coulter, Inc. · Jun 2000
ELECSYS THYROGLOBULIN CALCHECK
K001015 · Roche Diagnostics Corp. · Apr 2000
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
K992781 · Bio-Rad · Apr 2000
ELECSYS B-CROSSLAPS CALCHECK
K000042 · Roche Diagnostics Corp. · Mar 2000