Cleared Traditional

K881773 - DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET

K881773 is the FDA 510(k) clearance for DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET by Casco Standards. It is a Class 1 Chemistry device (product code JJR) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K881773 · Casco Standards · Chemistry device
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Jun 1988
Decision
45d
Days
Class 1
Risk

K881773 is an FDA 510(k) clearance for the DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET. Classified as Electrolyte Controls (assayed And Unassayed) (product code JJR), Class I - General Controls.

Submitted by Casco Standards (Yarmouth, US). The FDA issued a Cleared decision on June 10, 1988 after a review of 45 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 K881773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1988
Decision Date June 10, 1988
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJR Electrolyte 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 - JJR Electrolyte Controls (assayed And Unassayed)

All 8
Devices cleared under the same product code (JJR) and FDA review panel - the closest regulatory comparables to K881773.
SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING
K943925 · Quantimetrix Corp. · Oct 1994
CIBA CORNING CERTAIN LYTE
K894576 · Ciba Corning Diagnostics Corp. · Oct 1989
QCLYTE PROTEIN-BASED ISE CONTROL
K895582 · Baxter Healthcare Corp · Oct 1989
PROTEIN BASE ISE CONTROL
K880710 · Bionostics, Inc. · Mar 1988
HUMAN SERUM ELECTROLYTE CONTROL-LIQUID
K834505 · Quantimetrix Corp. · Apr 1984