Cleared Traditional

K860906 - STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III

K860906 is an FDA 510(k) clearance for STRATUS IMMUNOASSAY CONTROLS, manufactured by American Dade. The device is a Class 1 Toxicology device with product code JJY cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K860906 · American Dade · Toxicology device
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May 1986
Decision
80d
Days
Class 1
Risk

K860906 is an FDA 510(k) clearance for the STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on May 29, 1986 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1660 - the FDA toxicology device 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

FDA 510(k) Submission Details - K860906

510(k) Number K860906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1986
Decision Date May 29, 1986
Days to Decision 80 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 87d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

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 594
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K860906.
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
K862185 · Bio-Rad · Aug 1986
UTAK-STABBS TOXICOLOGY CONTROL
K862420 · Utak Laboratories, Inc. · Aug 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED
K860999 · Ciba Corning Diagnostics Corp. · Jul 1986
QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID
K860942 · Quantimetrix Corp. · May 1986
THERACHEM-PLUS, TRI-LEVEL TDC (TM)
K861185 · Fisher Scientific Co., LLC · May 1986
CONTROL SERA LEVEL VALUES (MG/DL)
K861567 · E.I. Dupont DE Nemours & Co., Inc. · May 1986