Cleared Traditional

K822850 - MONI-TRO ES CHEMISTRY CONTROL LEVEL IX

K822850 is the FDA 510(k) clearance for MONI-TRO ES CHEMISTRY CONTROL LEVEL IX by American Dade. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K822850 · American Dade · Chemistry device
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Oct 1982
Decision
34d
Days
Class 1
Risk

K822850 is an FDA 510(k) clearance for the MONI-TRO ES CHEMISTRY CONTROL LEVEL IX. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on October 27, 1982 after a review of 34 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 American Dade devices

Submission Details

510(k) Number K822850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1982
Decision Date October 27, 1982
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 K822850.
IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS
K823352 · American Dade · Feb 1983
MULTIANALYTE CONTROLS-ALL KINDS
K823929 · Fisher Scientific Co., LLC · Jan 1983
ORTHO BI-LEVEL ASSAYED LIPID PROFILE
K823490 · Ortho Diagnostic Systems, Inc. · Jan 1983
TITAN GEL SERUM CONTROL
K821982 · Helena Laboratories · Aug 1982
BI-LEVEL ASSAYED TUMOR MARKER & ANTIN
K821026 · Ortho Diagnostic Systems, Inc. · Aug 1982
IGE/THE OPHYLLINE CONTROL SERUM I,II,III
K822133 · Kallestad Laboratories, Inc. · Aug 1982