Cleared Traditional

K822698 - GLUCOSCAN CONTROLS

K822698 is the FDA 510(k) clearance for GLUCOSCAN CONTROLS by Lifescan, Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K822698 · Lifescan, Inc. · Chemistry device

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Sep 1982

Decision

23d

Days

Class 1

Risk

K822698 is an FDA 510(k) clearance for the GLUCOSCAN CONTROLS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Lifescan, Inc. (Walker, US). The FDA issued a Cleared decision on September 30, 1982 after a review of 23 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	K822698 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 07, 1982
Decision Date	September 30, 1982
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

65d faster than avg

Panel avg: 88d · This submission: 23d

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 K822698.

PHADEBAS HUMYLASE CONTROL(H)

K823421 · Pharmacia, Inc. · Apr 1983

BIO INTERFERENCE BLANKING MATERIAL

K823687 · American Monitor Corp. · Jan 1983

PHADEBASE HUMYLASE CONTROL

K822938 · Pharmacia, Inc. · Nov 1982

POSITIVE & NEGATIVE HCG URINE CONTROLS

K821742 · Armkel, LLC · Jul 1982

FETAL-TEK CONTROL (IMMATURE/BORDERLINE)

K820772 · Helena Laboratories · May 1982

C-PEPTIDE CONTROL PACK

K812690 · Mallinckrodt Critical Care · Oct 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K822698

Lifescan, Inc.

Walker, MI · US

Regulatory profile

42 submissions 42 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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