Cleared Traditional

K884197 - DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET

K884197 is the FDA 510(k) clearance for DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET by Casco Standards. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K884197 · Casco Standards · Chemistry device
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Dec 1988
Decision
69d
Days
Class 2
Risk

K884197 is an FDA 510(k) clearance for the DOCUMENT(TM) 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 December 14, 1988 after a review of 69 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

Submission Details

510(k) Number K884197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1988
Decision Date December 14, 1988
Days to Decision 69 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
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 159
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K884197.
COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.
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K882259 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1988
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