Cleared Traditional

CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM (K884227) - FDA 510(k) Clearance

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

K884227 · A-Kem, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
64d
Days
Class 2
Risk

K884227 is an FDA 510(k) clearance for the CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by A-Kem, Inc. (Clifton, US). The FDA issued a Cleared decision on December 9, 1988 after a review of 64 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 A-Kem, Inc. devices

Submission Details

510(k) Number K884227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1988
Decision Date December 09, 1988
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
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 88
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K884227.
PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II
K903913 · Baxter Healthcare Corp · Sep 1990
COBAS READY CALIBRATOR KIT
K897097 · Roche Diagnostic Systems, Inc. · Jun 1990
ROCHE STANDARDS FOR THE COBAS ISE MODULE
K897071 · Roche Diagnostic Systems, Inc. · Mar 1990
PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II
K881258 · Baxter Healthcare Corp · May 1988
PARAMAX URINE/CSF CALIBRATOR
K874587 · Baxter Healthcare Corp · Jan 1988
EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95
K871638 · Em Diagnostic Systems, Inc. · May 1987