Cleared Traditional

K897177 - CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE

K897177 is an FDA 510(k) clearance for CALIBRATORS, manufactured by Nova Biomedical 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.

K897177 · Nova Biomedical Corp. · Chemistry device
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Mar 1990
Decision
90d
Days
Class 2
Risk

K897177 is an FDA 510(k) clearance for the CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on March 27, 1990 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 Nova Biomedical Corp. devices

FDA 510(k) Submission Details - K897177

510(k) Number K897177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1989
Decision Date March 27, 1990
Days to Decision 90 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
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 269
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K897177.
PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II
K903913 · Baxter Healthcare Corp · Sep 1990
MULTI ANALYTE MIXTURE, CALIBRATORS
K902675 · Phoenix Diagnostics, Inc. · Jul 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
SODIUM AND POTASSIUM STANDARD
K895717 · Data Medical Associates, Inc. · Jan 1990
HI CHEM CALIBRATOR A+
K895135 · Hichem Diagnostics · Oct 1989