Cleared Traditional

K910962 - CHOLESTEROL CALIBRATOR SET

K910962 is an FDA 510(k) clearance for CHOLESTEROL CALIBRATOR SET, manufactured by Casco Standards. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K910962 · Casco Standards · Chemistry device
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Mar 1991
Decision
23d
Days
Class 2
Risk

K910962 is an FDA 510(k) clearance for the CHOLESTEROL CALIBRATOR SET. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Casco Standards (Yarmouth, US). The FDA issued a Cleared decision on March 29, 1991 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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

FDA 510(k) Submission Details - K910962

510(k) Number K910962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1991
Decision Date March 29, 1991
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 216
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K910962.
FLUIDS PACK
K944516 · Alko Diagnostic Corp. · Nov 1994
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TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL
K913371 · Creative Laboratory Products, Inc. · Nov 1991
ELECTROPHORESIS CONTROL
K910160 · Seradyn, Inc. · Feb 1991
SECONDARY CALIBRATORS
K904698 · Bionostics, Inc. · Nov 1990
COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
K895648 · Ventrex Laboratories, Inc. · Jan 1990