Cleared Traditional

K821026 - BI-LEVEL ASSAYED TUMOR MARKER & ANTIN

K821026 is the FDA 510(k) clearance for BI-LEVEL ASSAYED TUMOR MARKER & ANTIN by Ortho Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K821026 · Ortho Diagnostic Systems, Inc. · Chemistry device
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Aug 1982
Decision
119d
Days
Class 1
Risk

K821026 is an FDA 510(k) clearance for the BI-LEVEL ASSAYED TUMOR MARKER & ANTIN. 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 August 10, 1982 after a review of 119 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K821026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1982
Decision Date August 10, 1982
Days to Decision 119 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
31d slower than avg
Panel avg: 88d · This submission: 119d
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 K821026.
ORTHO BI-LEVEL ASSAYED LIPID PROFILE
K823490 · Ortho Diagnostic Systems, Inc. · Jan 1983
MONI-TRO ES CHEMISTRY CONTROL LEVEL IX
K822850 · American Dade · Oct 1982
TITAN GEL SERUM CONTROL
K821982 · Helena Laboratories · Aug 1982
IGE/THE OPHYLLINE CONTROL SERUM I,II,III
K822133 · Kallestad Laboratories, Inc. · Aug 1982
CHEMISTRY CONTROL/STANDARD
K821382 · Medical Analysis Systems, Inc. · May 1982
RESPONSE LIQUID LIGAND ASSAY SERUM
K821242 · Beckman Instruments, Inc. · May 1982