The Calcium test system is intended for in vitro diagnostic use in the quantitative determination of the calcium concentration in human serum or plasma on T60 instruments. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

Device Description

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AI/ML Overview

The provided text describes the Thermo Fisher Scientific Calcium Test System (Calcium, sCal, Nortrol, Abtrol) and its substantial equivalence to a predicate device, the Bayer ADVIA Calcium assay. The information largely focuses on comparing performance metrics between the new device and the predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, structured according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a set of pre-defined thresholds the new device had to meet. Instead, it presents a comparison table (Table 1) of various performance attributes between the new device (Calcium) and the predicate device (Bayer ADVIA Calcium assay). The implicit "acceptance" is that the new device's performance is substantially equivalent to or better than the predicate's.

Attribute	Acceptance Criteria (Implicit - based on predicate)	New Device Performance (Calcium)	Predicate Device Performance (Bayer ADVIA Calcium assay)
Intended Use	Similar quantitative determination of calcium in human serum/plasma	For quantitative determination of calcium in human serum or plasma on T60 instruments.	For quantitative determination of calcium in human serum, plasma (lithium heparin), and urine on ADVIA Chemistry systems.
Indication for Use	Similar diagnostic and treatment uses for parathyroid disease, bone diseases, renal disease, and tetany	Diagnosis and treatment of parathyroid disease, bone diseases, chronic renal disease and tetany.	Same as intended use.
Assay Protocol	Comparable method for calcium detection	Calcium ions form a highly coloured complex with Arsenazo III at neutral pH, measured at 660 nm.	Calcium ions form a violet complex with o-cresolphthalein complexone in an alkaline medium, measured at 545/658 nm.
Traceability/ Standardization	Traceable to recognized standard	NIST SRM 909b as a primary reference.	Traceable to a NIST atomic absorption reference method, using NIST reference materials via patient sample correlation.
Sample Type	Serum, plasma (Li-heparin)	Serum, plasma (Li-heparin)	Serum, plasma (Li-heparin) and urine.
Reagent Storage	Stable under specified conditions	2-25°C until expiration date, away from sunlight.	15-25°C until expiration date, do not freeze.
Expected Values (Serum/plasma)	Comparable range for normal values	8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l)	8.3 - 10.6 mg/dL (2.08 - 2.65 mmol/L)
Instrument	Compatible with clinical chemistry analyzers	T60 and DPC T60i, DPC T60i Kusti.	ADVIA® 2400 Chemistry system.
Measuring Range (Serum/plasma)	Comparable analytical measurement range	2.8 - 16.0 mg/dl (0.70 - 4.00 mmol/l)	1.0 - 15.0 mg/dL (0.25 - 3.75 mmol/L)
Precision (Within-run Serum)	Low SD and CV(%) values across levels	Level 4.0 mg/dL: SD=0.04, CV(%)=1.0; Level 8.4 mg/dL: SD=0.07, CV(%)=0.8; Level 11.9 mg/dL: SD=0.08, CV(%)=0.7	Level 6.2 mg/dL: SD=0.06, CV(%)=1.0; Level 8.5 mg/dL: SD=0.17, CV(%)=2.0; Level 10.9 mg/dL: SD=0.18, CV(%)=1.6
Precision (Total Serum)	Low SD and CV(%) values across levels	Level 4.0 mg/dL: SD=0.06, CV(%)=1.6; Level 8.4 mg/dL: SD=0.12, CV(%)=1.5; Level 11.9 mg/dL: SD=0.18, CV(%)=1.5	Level 6.2 mg/dL: SD=0.12, CV(%)=2.0; Level 8.5 mg/dL: SD=0.21, CV(%)=2.4; Level 10.9 mg/dL: SD=0.23, CV(%)=2.1
Method Comparison (Serum)	Strong correlation with predicate (R close to 1, slope close to 1, intercept close to 0)	y = 1.04x - 0.002, R = 0.994	y = 1.01x +0.27, R = 0.988 (vs ADVIA 1650); y = 1.00x - 0.56, R = 0.996 (vs reference method)
Limitations (Lipemia)	No significant interference up to a certain concentration	No interference found up to 1000 mg/dL (10 g/l) of Intralipid.	No significant interference found up to 625 mg/dl of Intralipid.
Limitations (Hemolysate)	No significant interference up to a certain concentration	No interference found up to 1000 mg/dl (10 g/l) of hemoglobin.	No significant interference found up to 525 mg/dl of hemoglobin.
Limitations (Bilirubin, conjugated)	No significant interference up to a certain concentration	No interference found up to 58 mg/dL (1000 µmol/l).	Not specified, but predicate states no significant interference up to 30 mg/dl for general Bilirubin.
Limitations (Bilirubin, unconjugated)	No significant interference up to a certain concentration	No interference found up to 58 mg/dL (1000 µmol/l).	Not specified, but predicate states no significant interference up to 30 mg/dl for general Bilirubin.

2. Sample Size Used for the Test Set and Data Provenance

Method Comparison (Serum):
- Sample Size: N = 112
- Data Provenance: Not explicitly stated, but it's a comparison to the Bayer ADVIA 2400. Given the submission is from Thermo Fisher Scientific Oy in Finland, and the clinical chemistry context, it's highly likely to be prospective clinical samples, but the country of origin is not specified. It is an in vitro diagnostic device, so the samples used for this study would be human serum/plasma.
Precision Studies:
- Sample Size: Not explicitly stated as "N" for the precision studies, but rather by "levels" (e.g., Level 4.0 mg/dL). Typically, precision studies involve running a sample multiple times within a run and across multiple runs. The 'SD' and 'CV(%)' values are calculated from these repeated measurements. The exact number of replicates is not provided.
- Data Provenance: Not explicitly stated. Likely laboratory-prepared control samples or spiked patient samples.
Limitations (Interference):
- Sample Size: Not explicitly stated. Interference studies typically involve spiking samples with known interferents at various concentrations.
- Data Provenance: Not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For this type of in vitro diagnostic device (a chemical assay), the "ground truth" is established through analytical reference methods or highly accurate laboratory instruments, not by human experts in the way image analysis or clinical diagnosis might be.

Method Comparison: The new device was compared to the predicate device (Bayer ADVIA 2400). The predicate device itself would have been validated against a reference method. The text also mentions the Bayer ADVIA Calcium assay's traceability to a NIST atomic absorption reference method.
Traceability: The new device's value has been assigned by using NIST SRM 909b as a primary reference. This implies that NIST standards and reference methods are the "ground truth" for calibrating and validating the assay.

Therefore, there were no human "experts" establishing ground truth in the sense of clinical reviewers for this device. The ground truth relies on established analytical standards and reference measurement procedures.

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro diagnostic assay, adjudication methods such as 2+1 or 3+1 (often used in clinical image interpretation) are not relevant. The "adjudication" is inherent in the analytical process, where results are compared against reference methods or statistically analyzed for agreement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is not an AI-assisted diagnostic tool or an imaging device requiring human interpretation. It is a chemical reagent and calibrator system for measuring calcium concentration. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, the entire performance evaluation presented is "standalone" for the device itself. The studies on precision, measuring range, and interference demonstrate the performance of the Calcium test system (reagents, calibrators, and the T60 instrument) independently. The method comparison study also assesses the direct output of the new device relative to the predicate without human intervention in result generation.

7. The Type of Ground Truth Used

The ground truth used for establishing the performance and enabling substantial equivalence determination includes:

NIST Standards: NIST SRM 909b for primary reference, and the predicate's traceability to a NIST atomic absorption reference method. (This is a form of highly certified reference measurement procedure/material).
Predicate Device Output: The Bayer ADVIA 2400 Chemistry System's Calcium assay served as the comparative "ground truth" for the method comparison study. The predicate itself would have been validated against a reference standard.
Laboratory Control Materials/Spiked Samples: Likely used for precision and interference studies.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device that requires a "training set" in the computational sense. It is a chemical reagent-based assay. Its performance is characterized through traditional analytical validation, not by training an algorithm on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this chemical assay device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are in bold, and the word "SCIENTIFIC" is in a smaller, non-bold font. The logo is simple and professional.

510(k) SUMMARY

This Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

K073355 The assigned 510(k) number is:

A. Introduction:

According to the requirements of 21 CFR 807.92 the following information provides sufficent detail to understand the basis for a determination of substantial equivalence.

Submitter's information B.

Name:	Thermo Fisher Scientific Oy
Address:	Ratastie 2
	P.O. Box 100
	FIN-01621 Vantaa
	Finland
Phone:	+358 (9) 329 100 tel
Fax:	+358 (9) 3291 0500 fax
Contact person:	Päivi Sormunen, Vice President of QRC
Date of Preparation:	November 23rd , 2007

sCal, code 981831

C. Device name

Proprietary name: Common name: Classification: Class: Product Code:

Calcium, codes 981367 and 981772 Calcium Clinical Chemistry II CIY

Proprietary name: Common Name: Classification: Class: Product Code:

Calibrator, Multi-Analyte Mixture Clinical Chemistry II JIX

Nortrol, code 981043 Multi-analyte Controls (Assayed and unassayed) Clinical Chemistry I JJY

Proprietary name: Common Name: Classification: Class: Product Code:

Abtrol, code 981044 Multi-analyte Controls (Assayed and unassayed) Clinical Chemistry I

JJY

Thermo Fisher Scientific Oy

Ratastie 2 P.O. Box 100 FIN-01621 Vantaa Finland

+358 (9) 329 100 tel +358 (9) 3291 0500 fax

Y -tunnus (1921547-0 VAT No FI09215470 Domicile Helsinki

www.thermo.com

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D. Intended Use

Calcium

For in vitro diagnostic use in the quantitative determination of the calcium concentration in human serum or plasma on T60 instruments.

sCal, code 981831

For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

Nortrol

Abtrol

E. Indications for use

For sCal Calibrator, Nortrol and Abtrol see intended use.

F. Substantial Equivalence

Bayer Corporation, model Bayer ADVIA 2400 Chemistry System.

Bayer Corporation item: Bayer ADVIA Calcium assay.

G. Substantial equivalence -similarities

Calcium is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Bayer ADVIA Calcium assay (K991576).

+358 (9) 329 100 tel +358 (9) 3291 0500 fax Y-tunnus 0921547-0 VAT No F109215470 Domicile Helsinki

www.thermo.com

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The following table compares the Calcium with the predicate device
Table 1

Attribute	New device #1	Predicate device #1
Intended Use	For in vitro diagnostic use in thequantitative determination of thecalcium concentration in humanserum or plasma on T60instruments.	For in vitro diagnostic use inthe quantitative determinationof calcium in human serum,plasma (lithium heparin), andurine on the ADVIAChemistry systems. Suchmeasurements are used in thediagnosis and treatment ofparathyroid disease, avariety of bone diseases,chronic renal failure, andtetany.
Indication for Use	The Calcium test system isintended for quantitative in vitrodiagnostic measurement ofcalcium concentration in humanserum or plasma. Calciummeasurements are used in thediagnosis and treatment ofparathyroid disease, a variety ofbone diseases, chronic renaldisease and tetany	See intended use.
Assay Protocol	Calcium ions form a highlycoloured complex with ArsenazoIII at neutral pH. The amount ofthe complex is measured at 660nm.	Calcium ions form a violetcomplex with o -cresolphthalein complexone inan alkaline medium. Thereaction is measured at545/658 nm.
Traceability/Standardization	The value of Calcium has beenassigned by using NIST SRM909b as a primary reference	The ADVIA CA method istraceable to a NIST atomicabsorption reference method,which uses reference materialsfrom the National Institute ofStandards andTechnology (NIST), viapatient sample correlation.
Sample Type	Serum, plasma (Li-heparin)	Serum, plasma (Li-heparin)and urine
Reagent Storage	Reagents in unopened vials arestable at 2...25°C until theexpiration date printed on thelabel. Keep away from sunlight.	For all systems, unopenedreagents are stable until theexpiration date printed on theproduct label when stored at15° - 25°C. Do not freezereagents.
Expected Values	Serum/ plasma	Serum/Plasma:
	8.6 - 10.3 mg/dl(2.15 - 2.57 mmol/l)	8.3 - 10.6 mg/dL(2.08 - 2.65 mmol/L)
		Urine:100 - 300 mg/day(2.50 - 7.50 mmol/day)
Instrument	T60 and DPC T60i, DPC T60iKusti	ADVIA® 2400 Chemistrysystem.
Measuring Range	Serum/ plasma2.8 - 16.0 mg/dl(0.70 - 4.00 mmol/l)	Serum/ Plasma:1.0 - 15.0 mg/dL(0.25 - 3.75 mmol/L)
		Urine:1.0 - 30.0 mg/dL(0.25 - 7.50 mmol/L)
Precision	Serum:Within runLevel 4.0 mg/ dLSD= 0.04CV(%)= 1.0Level 8.4 mg/ dLSD= 0.07CV(%)=0.8Level 11.9 mg/ dLSD=0.08CV(%)=0.7Between runLevel 4.0 mg/ dLSD= 0.02CV(%)=0.6Level 8.4 mg/ dLSD= 0.03CV(%)=0.4Level 11.9 mg/ dLSD= 0.08CV(%)=0.7TotalLevel 4.0 mg/ dLSD= 0.06CV(%)= 1.6Level 8.4 mg/ dLSD=0.12CV(%)= 1.5Level 11.9 mg/ dLSD= 0.18CV(%)= 1.5	Serum:Within runLevel 6.2 mg/dLSD= 0.06CV(%)= 1.0Level 8.5 mg/dLSD=0.17CV(%)= 2.0Level 10.9 mg/dLSD=0.18CV(%)= 1.6TotalLevel 6.2 mg/dLSD=0.12CV(%)= 2.0Level 8.5 mg/dLSD= 0.21CV(%)=2.4Level 10.9 mg/dLSD= 0.23CV(%)= 2.1Urine:Within runLevel 5.8 mg/dLSD= 0.10CV(%)= 1.7Level 12.7 mg/dLSD= 0.08CV(%)=0.6
		Total
		Level 5.8 mg/dLSD=0.12CV(%)= 2.1Level 12.7 mg/dLSD=0.64CV(%)= 5.1
Method Comparison	Serum (Comparison to Bayer ADVIA 2400):	Serum (comparison to ADVIA 1650):
	y = $1.04 x - 0.002$R = 0.994range from 0.44 to 18.25 mg/dLN = 112	y = $1.01x +0.27$R = 0.988Range: 4.6 - 12.1 mg/dLN = 242
		Serum (comparison to reference method):
		y = $1.00x - 0.56$R = 0.996Range: 2.5 - 13.9 mg/dLN = 48
		Urine (comparison to ADVIA 1650):
		y = $0.98x + 0.23$R = 0.999Range: 1.0 - 15.0 mg/dLN = 64
Limitations	Lipemia:	Lipemia (from Intralipid):
	No interference found up to 1000mg/dL (10 g/l) of Intralipid.	No significant interferencefound up to 625 mg/dl ofIntralipid.
	Hemolysate:
	No interference found up to 1000mg/dl (10 g/l) of hemoglobin	Hemolysate:
		No significant interferencefound up to 525 mg/dl ofhemoglobin.
	Bilirubin, conjugated:
	No interference found up to 58mg/dL (1000 µmol/l) ofconjugated bilirubin.	Bilirubin:
	Bilirubin, unconjugated:	No significant interferencefound up to 30 mg/dl.
	No interference found up to 58mg/dL (1000 µmol/l) ofunconjugated bilirubin.

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Thermo Fisher Scientific Oy

Ratastic 2
P.O. Box 100
FIN-01621 Vantaa
Fini-01621 Vantaa
Finland

+358 (9) 329 100 tel
+358 (9) 3291 0500 fax

Y-tunnus 092 l 547-0
VAT No FI09215470
Domicile Helsinki

ww.themo.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

FEB 2 8 2008

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Thermo Fisher Scientific Oy c/o Päivi Sormunen Vice President of Industrial Solutions & QRC Clinical Diagnostics Finland Ratastie 2, P.O. Box 100 Fin-01621 Vantaa Finland

Re: K073355 Trade Name: Calcium, sCal, Nortrol, Abtrol Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium Test System Regulatory Class: Class II Product Codes: CJY, JIX, JJY Dated: January 24, 2008 Received: January 28, 2008

Dear Päivi Sormunen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Calcium, sCal, Nortrol, Abtrol

The Calcium test system is intended for quantitative in vitro diagnostic measurement of calcium concentration in human serum or plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany

For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073355

Regulation Number and Section

§ 862.1145 Calcium test system.

(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.