Cleared Traditional

K981578 - CA

K981578 is an FDA 510(k) clearance for CA, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CJY cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K981578 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
43d
Days
Class 2
Risk

K981578 is an FDA 510(k) clearance for the CA. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Abbott Laboratories (Dallas, US). The FDA issued a Cleared decision on June 16, 1998 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K981578

510(k) Number K981578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1998
Decision Date June 16, 1998
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJY Device Classification - Class 2, Special Controls

Product Code CJY Azo Dye, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - CJY Azo Dye, Calcium

All 34
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K981578.
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RANDOX CALCIUM
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SIGMA DIAGNOSTICS CALICIUM REAGENT
K963536 · Sigma Diagnostics, Inc. · Oct 1996
EKTACHEM CLINICAL CHEMISTRY CALCIUM (CA) SLIDE
K961226 · Johnson & Johnson Clinical Diagnostics, Inc. · May 1996