Cleared Traditional

K902458 - ACS 0.02 M CALCIUM CHLORIDE

K902458 is the FDA 510(k) clearance for ACS 0.02 M CALCIUM CHLORIDE by Analytical Control Systems, Inc.. It is a Class 2 Chemistry device (product code JPA) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K902458 · Analytical Control Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
58d
Days
Class 2
Risk

K902458 is an FDA 510(k) clearance for the ACS 0.02 M CALCIUM CHLORIDE. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Analytical Control Systems, Inc. (Fishers, US). The FDA issued a Cleared decision on August 1, 1990 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.5425 - 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 Analytical Control Systems, Inc. devices

Submission Details

510(k) Number K902458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1990
Decision Date August 01, 1990
Days to Decision 58 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
30d faster than avg
Panel avg: 88d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K902458.
KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM
K914188 · Ortho Diagnostic Systems, Inc. · Aug 1992
ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS
K912087 · Instrumentation Laboratory CO · Sep 1991
HEPARIN ADSORBENT
K912061 · Sigma Diagnostics, Inc. · Jul 1991
COAG-A-MATE - RA4
K900917 · Organon Teknika Corp. · Apr 1990
COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN
K900377 · Baxter Healthcare Corp · Mar 1990
PLATELET AGGREGATION PROFILER MODEL PAP-4C
K893650 · Bio/Data Corp. · Jun 1989