Cleared Traditional

K955154 - CAL 1 & CAL 2 SOLUTION

K955154 is the FDA 510(k) clearance for CAL 1 & CAL 2 SOLUTION by Alko Diagnostic Corp.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K955154 · Alko Diagnostic Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
28d
Days
Class 2
Risk

K955154 is an FDA 510(k) clearance for the CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT. 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 December 11, 1995 after a review of 28 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 K955154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date December 11, 1995
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 202
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K955154.
N PROTEIN STANDARD PY
K962410 · Behring Diagnostics, Inc. · Jul 1996
CALIBRATION SERUM LEVEL 1 & 2
K955489 · Randox Laboratories, Ltd. · Jun 1996
CEDIA CORE TDM MULTI-CAL
K961659 · Boehringer Mannheim Corp. · Jun 1996
APOLIPOPROTEIN CALIBRATOR (APO-CAL)
K953979 · Beckman Instruments, Inc. · Oct 1995
ROCHE CALIBRATOR SERUM
K942706 · Roche Diagnostic Systems, Inc. · Sep 1995
ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR
K952282 · Roche Diagnostic Systems, Inc. · Sep 1995