Cleared Traditional

K020883 - ELECSYS PROBNP CALCHECK

K020883 is the FDA 510(k) clearance for ELECSYS PROBNP CALCHECK by Roche Diagnostics Corp.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K020883 · Roche Diagnostics Corp. · Chemistry device
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Nov 2002
Decision
256d
Days
Class 1
Risk

K020883 is an FDA 510(k) clearance for the ELECSYS PROBNP 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 November 29, 2002 after a review of 256 days - an extended review 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: 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K020883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2002
Decision Date November 29, 2002
Days to Decision 256 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
168d slower than avg
Panel avg: 88d · This submission: 256d
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 K020883.
MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL
K031890 · Medical Analysis Systems, Inc. · Jul 2003
SAS RSV CONTROL KIT
K030628 · Sa Scientific, Inc. · Mar 2003
WAKO NEFA LINEARITY SET
K030065 · Wako Chemicals USA, Inc. · Feb 2003
MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL
K023307 · Medical Analysis Systems, Inc. · Oct 2002
ELECSYS ANTI-TG CALCHECK
K020369 · Roche Diagnostics Corp. · Mar 2002
N LP(A) CONTROL SY
K013130 · Dade Behring, Inc. · Oct 2001