Cleared Traditional

K894804 - SINGLE (SPECIFIED) ANALYTE CONTROL (ASS...

K894804 is the FDA 510(k) clearance for SINGLE (SPECIFIED) ANALYTE CONTROL (ASS... by Lifescan, Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K894804 · Lifescan, Inc. · Chemistry device
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Sep 1989
Decision
62d
Days
Class 1
Risk

K894804 is an FDA 510(k) clearance for the SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED). Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Lifescan, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 28, 1989 after a review of 62 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 Lifescan, Inc. devices

Submission Details

510(k) Number K894804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1989
Decision Date September 28, 1989
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
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 275
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K894804.
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K895528 · Helena Laboratories · Oct 1989
RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL
K894329 · Amersham Corp. · Sep 1989
POSITIVE AND NEGATIVE HCG URINE CONTROLS
K894181 · Armkel, LLC · Aug 1989
LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3
K891475 · Bio-Rad · Aug 1989