Cleared Traditional

K833097 - CHEM TRAK LIQUID BILIRUBIN CONTROL

K833097 is an FDA 510(k) clearance for CHEM TRAK LIQUID BILIRUBIN CONTROL, manufactured by Medical Analysis Systems, Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K833097 · Medical Analysis Systems, Inc. · Chemistry device
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Jan 1984
Decision
121d
Days
Class 1
Risk

K833097 is an FDA 510(k) clearance for the CHEM TRAK LIQUID BILIRUBIN CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Medical Analysis Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1984 after a review of 121 days - within the typical 510(k) review window.

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 Medical Analysis Systems, Inc. devices

FDA 510(k) Submission Details - K833097

510(k) Number K833097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1983
Decision Date January 11, 1984
Days to Decision 121 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
33d slower than avg
Panel avg: 88d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

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 444
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K833097.
BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3
K851079 · Beckman Instruments, Inc. · Apr 1985
PRECISET AMMONIA
K843569 · Boehringer Mannheim Corp. · Sep 1984
TRI-LEVEL BILIRUBIN CONTROLS
K833898 · Sandare Chemical Co., Inc. · Jan 1984
SPINAL FLUID TOTAL PROTEIN CONTROL
K831527 · Quantimetrix Corp. · Jul 1983
PHADEBAS HUMYLASE CONTROL(H)
K823421 · Pharmacia, Inc. · Apr 1983
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K830204 · Wellcome Diagnostics · Feb 1983