Cleared Traditional

K823490 - ORTHO BI-LEVEL ASSAYED LIPID PROFILE

K823490 is the FDA 510(k) clearance for ORTHO BI-LEVEL ASSAYED LIPID PROFILE by Ortho Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K823490 · Ortho Diagnostic Systems, Inc. · Chemistry device
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Jan 1983
Decision
43d
Days
Class 1
Risk

K823490 is an FDA 510(k) clearance for the ORTHO BI-LEVEL ASSAYED LIPID PROFILE. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on January 5, 1983 after a review of 43 days - a notably fast clearance 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: 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K823490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1982
Decision Date January 05, 1983
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K823490.
ELECTROPHORESIS CONTROLS-3 IN 1
K831263 · Corning Medical & Scientific · Jul 1983
IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS
K823352 · American Dade · Feb 1983
MULTIANALYTE CONTROLS-ALL KINDS
K823929 · Fisher Scientific Co., LLC · Jan 1983
MONI-TRO ES CHEMISTRY CONTROL LEVEL IX
K822850 · American Dade · Oct 1982
TITAN GEL SERUM CONTROL
K821982 · Helena Laboratories · Aug 1982
BI-LEVEL ASSAYED TUMOR MARKER & ANTIN
K821026 · Ortho Diagnostic Systems, Inc. · Aug 1982