Cleared Traditional

K073355 - CALCIUM, SCAL, NORTROL, ABTROL

K073355 is an FDA 510(k) clearance for CALCIUM, manufactured by Thermofisher Scientific OY. The device is a Class 2 Chemistry device with product code CJY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K073355 · Thermofisher Scientific OY · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
91d
Days
Class 2
Risk

K073355 is an FDA 510(k) clearance for the CALCIUM, SCAL, NORTROL, ABTROL. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Thermofisher Scientific OY (Vantaa, FI). The FDA issued a Cleared decision on February 28, 2008 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Thermofisher Scientific OY devices

FDA 510(k) Submission Details - K073355

510(k) Number K073355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2007
Decision Date February 28, 2008
Days to Decision 91 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
3d slower than avg
Panel avg: 88d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJY Device Classification - Class 2, Special Controls

Product Code CJY Azo Dye, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 - CJY Azo Dye, Calcium

All 41
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K073355.
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
K123171 · HORIBA ABX SAS · Jul 2013
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
K083386 · Siemens Healthcare Diagnostics · Apr 2009
S-TEST CA
K072356 · Alfa Wassermann Diagnostic Technologies, Inc. · Jun 2008
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
K072443 · Ortho-Clinical Diagnostics, Inc. · Sep 2007
VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)
K072440 · Ortho-Clinical Diagnostics, Inc. · Sep 2007
CALCIUM
K062855 · Abbott Laboratories · Nov 2006