Cleared Traditional

K001484 - CALIBRATION SOLUTION 1, MODEL A943-837 (FDA 510(k) Clearance)

Also includes:
CALIBRATION SOLUTION 2, MODEL A943-839 RINSE SOLUTION KIT, MODEL A943-838

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K001484 · Alko Diagnostic Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
39d
Days
Class 2
Risk

K001484 is an FDA 510(k) clearance for the CALIBRATION SOLUTION 1, MODEL A943-837. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on June 19, 2000 after a review of 39 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 Alko Diagnostic Corp. devices

Submission Details

510(k) Number K001484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2000
Decision Date June 19, 2000
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
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.