Cleared Special

K981436 - DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBR...

K981436 is the FDA 510(k) clearance for DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBR... by Casco Standards. It is a Class 2 Chemistry device (product code JIX) cleared through the Special 510(k) pathway after a 10-day FDA review.

K981436 · Casco Standards · Chemistry device
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Apr 1998
Decision
10d
Days
Class 2
Risk

K981436 is an FDA 510(k) clearance for the DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Casco Standards (Portland, US). The FDA issued a Cleared decision on April 24, 1998 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Casco Standards devices

Submission Details

510(k) Number K981436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1998
Decision Date April 24, 1998
Days to Decision 10 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 88d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 201
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K981436.
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OLYMPUS SERUM PROTEIN MULTICALIBRATOR
K981305 · Olympus America, Inc. · May 1998
BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS
K974825 · Boehringer Mannheim Corp. · Jan 1998
BECKMAN CALIBRATOR 2 (CAL2)
K973932 · Beckman Instruments, Inc. · Dec 1997
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K973928 · Beckman Instruments, Inc. · Dec 1997