Cleared Traditional

K833005 - PARAMAX BILIRUBIN CALIBRATORS

K833005 is the FDA 510(k) clearance for PARAMAX BILIRUBIN CALIBRATORS by American Dade. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K833005 · American Dade · Chemistry device
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Nov 1983
Decision
94d
Days
Class 2
Risk

K833005 is an FDA 510(k) clearance for the PARAMAX BILIRUBIN CALIBRATORS. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 American Dade devices

Submission Details

510(k) Number K833005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1983
Decision Date November 14, 1983
Days to Decision 94 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 88d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 201
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K833005.
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SERALYZER MULTICOMPONENT CALIBRATORS
K832046 · Miles Laboratories, Inc. · Aug 1983
COBAS STANDARDS FOR GLUCOSE & BUN
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