Cleared Traditional

K020369 - ELECSYS ANTI-TG CALCHECK

K020369 is the FDA 510(k) clearance for ELECSYS ANTI-TG CALCHECK by Roche Diagnostics Corp.. It is a Class 1 Immunology device (product code JJX) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K020369 · Roche Diagnostics Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
Mar 2002
Decision
30d
Days
Class 1
Risk

K020369 is an FDA 510(k) clearance for the ELECSYS ANTI-TG 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 March 6, 2002 after a review of 30 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 K020369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2002
Decision Date March 06, 2002
Days to Decision 30 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 104d · This submission: 30d
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 K020369.
WAKO NEFA LINEARITY SET
K030065 · Wako Chemicals USA, Inc. · Feb 2003
ELECSYS PROBNP CALCHECK
K020883 · Roche Diagnostics Corp. · Nov 2002
MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL
K023307 · Medical Analysis Systems, Inc. · Oct 2002
N LP(A) CONTROL SY
K013130 · Dade Behring, Inc. · Oct 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K011250 · Ortho-Clinical Diagnostics, Inc. · Jun 2001
VIGIL DNASE B CONTROL
K010693 · Beckman Coulter, Inc. · Apr 2001