Cleared Traditional

K940568 - DOCUMENT ZERO

K940568 is the FDA 510(k) clearance for DOCUMENT ZERO by Casco Standards. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K940568 · Casco Standards · Chemistry device

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Apr 1994

Decision

56d

Days

Class 1

Risk

K940568 is an FDA 510(k) clearance for the DOCUMENT(R) ZERO. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Casco Standards (Yarmouth, US). The FDA issued a Cleared decision on April 5, 1994 after a review of 56 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 Casco Standards devices

Submission Details

510(k) Number	K940568 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 08, 1994
Decision Date	April 05, 1994
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

32d faster than avg

Panel avg: 88d · This submission: 56d

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 372

Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K940568.

GLUCOMETER ELITE LOW CONTROL

K940577 · Heraeus Kulzer, Inc. · Jun 1994

ASSURE URINE HCG CONTROL

K941130 · Quantimetrix Corp. · Jun 1994

ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL

K940272 · Analytical Control Systems, Inc. · Apr 1994

CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET

K934922 · Unipath , Ltd. · Dec 1993

CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET

K934923 · Unipath , Ltd. · Dec 1993

SPQ MALB CONTROL LEVEL II

K934521 · Incstar Corp. · Nov 1993

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 K940568

Casco Standards

Yarmouth, ME · US

LENITY LARRABEE

Regulatory profile

38 submissions 38 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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