Cleared Traditional

K935018 - REAGENTS FOR ORION 1020

K935018 is an FDA 510(k) clearance for REAGENTS FOR ORION 1020, manufactured by Alko Diagnostic Corp.. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K935018 · Alko Diagnostic Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
90d
Days
Class 2
Risk

K935018 is an FDA 510(k) clearance for the REAGENTS FOR ORION 1020, AND RELATED ANALYZERS. 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 January 18, 1994 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Alko Diagnostic Corp. devices

FDA 510(k) Submission Details - K935018

510(k) Number K935018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1993
Decision Date January 18, 1994
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 230
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K935018.
ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM
K934607 · Alko Diagnostic Corp. · Mar 1994
ACA PLUS FERRITIN CALIBRATOR
K935543 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1994
REAGENTS FOR HITACHI ISE
K933383 · Alko Diagnostic Corp. · Mar 1994
CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER
K935547 · Alko Diagnostic Corp. · Jan 1994
REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)
K925385 · Alko Diagnostic Corp. · Jan 1994
CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR
K925464 · Alko Diagnostic Corp. · Jan 1994