Cleared Traditional

K944999 - SERUM BILIRUBIN CONTROL- LEVEL 1

K944999 is the FDA 510(k) clearance for SERUM BILIRUBIN CONTROL- LEVEL 1 by More Diagnostics. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K944999 · More Diagnostics · Chemistry device
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Jun 1995
Decision
236d
Days
Class 1
Risk

K944999 is an FDA 510(k) clearance for the SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on June 6, 1995 after a review of 236 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.

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Submission Details

510(k) Number K944999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1994
Decision Date June 06, 1995
Days to Decision 236 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 88d · This submission: 236d
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 371
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K944999.
OPUS HCG CONTROLS
K954144 · Behring Diagnostics, Inc. · Oct 1995
IMMULITE HCG HIGH LEVEL CONTROL MODULE
K952251 · Diagnostic Products Corp. · Sep 1995
OPUS T4 CONTROLS
K953097 · Behring Diagnostics, Inc. · Aug 1995
IMMULITE(R) TBG
K950072 · Diagnostic Products Corp. · Apr 1995
REP CHOLESTEROL PROFILE CONTROL
K950590 · Helena Laboratories · Mar 1995
SAS QUANT HCG SERUM
K944785 · Sa Scientific, Inc. · Jan 1995