CALCIUM, SCAL, NORTROL, ABTROL

K073355 · Thermofisher Scientific OY · CJY · Feb 28, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073355
• Device Name: CALCIUM, SCAL, NORTROL, ABTROL
• Applicant: Thermofisher Scientific OY
• Product Code: CJY · Clinical Chemistry
• Decision Date: Feb 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

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.

Device Story

The device is a quantitative in vitro diagnostic assay for measuring calcium concentration in human serum or plasma. It utilizes a liquid, ready-to-use reagent containing Arsenazo-III dye. When mixed with a patient sample, calcium ions react with the dye at neutral pH to form a colored complex. The intensity of this complex is measured spectrophotometrically at 660 nm on T60 or T60i clinical chemistry analyzers. The system includes a multicalibrator (sCal) and control sera (Nortrol, Abtrol) to ensure measurement accuracy and precision. The assay is intended for use by healthcare professionals in clinical laboratory settings. Results are used by clinicians to assess calcium levels, supporting the diagnosis and management of metabolic and bone-related disorders. The device provides a standardized, automated method for calcium quantification, replacing manual or older colorimetric methods.

Clinical Evidence

No clinical trials were performed. Evidence is based on analytical bench testing. Method comparison study (n=112) using Li-heparin plasma samples compared the subject device to the predicate, yielding a Deming regression of y = 1.03x + 0.096 (r = 0.987). Matrix comparison (n=97) between serum and plasma showed y = 0.95x + 0.373 (r = 0.990). Precision studies (CLSI EP5-A) showed total CVs of 1.5-1.6%. Linearity (CLSI EP6-A) confirmed a reportable range of 2.8–16.0 mg/dL. Interference testing (CLSI EP7-A) showed no significant interference from lipemia, hemoglobin, or bilirubin up to specified limits.

Technological Characteristics

Photometric assay using Arsenazo III reagent; measurement at 660 nm. Sample types: serum, Li-heparin plasma. Traceability to NIST SRM 909b. Instrument: T60/T60i clinical chemistry analyzers. Reagent stability 2-25°C. Software-controlled automated analysis.

Indications for Use

Indicated for quantitative measurement of calcium in human serum or plasma to aid in the diagnosis and treatment of parathyroid disease, bone diseases, chronic renal disease, and tetany.

Regulatory Classification

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).

Predicate Devices

• Bayer ADVIA Calcium assay (K991576)

Submission Summary (Full Text)

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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: | [phone] tel |
| Fax: | [phone] 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:

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

[phone] tel [phone] 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

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.

# Abtrol

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.

### E. Indications for use

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 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).

[phone] tel [phone] 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 <i>in vitro</i> diagnostic use in the<br>quantitative determination of the<br>calcium concentration in human<br>serum or plasma on T60<br>instruments. | For <i>in vitro</i> diagnostic use in<br>the quantitative determination<br>of calcium in human serum,<br>plasma (lithium heparin), and<br>urine on the ADVIA<br>Chemistry systems. Such<br>measurements are used in the<br>diagnosis and treatment of<br>parathyroid disease, a<br>variety of bone diseases,<br>chronic renal failure, and<br>tetany. |
| Indication for Use | The Calcium test system is<br>intended for quantitative <i>in vitro</i><br>diagnostic measurement of<br>calcium concentration in human<br>serum or plasma. Calcium<br>measurements are used in the<br>diagnosis and treatment of<br>parathyroid disease, a variety of<br>bone diseases, chronic renal<br>disease and tetany | See intended use. |
| Assay Protocol | Calcium ions form a highly<br>coloured complex with Arsenazo<br>III at neutral pH. The amount of<br>the complex is measured at 660<br>nm. | Calcium ions form a violet<br>complex with <i>o</i> -<br>cresolphthalein complexone in<br>an alkaline medium. The<br>reaction is measured at<br>545/658 nm. |
| Traceability/Standar<br>dization | The value of Calcium has been<br>assigned by using NIST SRM<br>909b as a primary reference | The ADVIA CA method is<br>traceable to a NIST atomic<br>absorption reference method,<br>which uses reference materials<br>from the National Institute of<br>Standards and<br>Technology (NIST), via<br>patient sample correlation. |
| Sample Type | Serum, plasma (Li-heparin) | Serum, plasma (Li-heparin)<br>and urine |
| Reagent Storage | Reagents in unopened vials are<br>stable at 2...25°C until the<br>expiration date printed on the<br>label. Keep away from sunlight. | For all systems, unopened<br>reagents are stable until the<br>expiration date printed on the<br>product label when stored at<br>15° - 25°C. Do not freeze<br>reagents. |
| Expected Values | Serum/ plasma | Serum/Plasma: |
| | 8.6 - 10.3 mg/dl<br>(2.15 - 2.57 mmol/l) | 8.3 - 10.6 mg/dL<br>(2.08 - 2.65 mmol/L) |
| | | Urine:<br>100 - 300 mg/day<br>(2.50 - 7.50 mmol/day) |
| Instrument | T60 and DPC T60i, DPC T60i<br>Kusti | ADVIA® 2400 Chemistry<br>system. |
| Measuring Range | Serum/ plasma<br>2.8 - 16.0 mg/dl<br>(0.70 - 4.00 mmol/l) | Serum/ Plasma:<br>1.0 - 15.0 mg/dL<br>(0.25 - 3.75 mmol/L) |
| | | Urine:<br>1.0 - 30.0 mg/dL<br>(0.25 - 7.50 mmol/L) |
| Precision | Serum:<br>Within run<br>Level 4.0 mg/ dL<br>SD= 0.04<br>CV(%)= 1.0<br>Level 8.4 mg/ dL<br>SD= 0.07<br>CV(%)=0.8<br>Level 11.9 mg/ dL<br>SD=0.08<br>CV(%)=0.7<br>Between run<br>Level 4.0 mg/ dL<br>SD= 0.02<br>CV(%)=0.6<br>Level 8.4 mg/ dL<br>SD= 0.03<br>CV(%)=0.4<br>Level 11.9 mg/ dL<br>SD= 0.08<br>CV(%)=0.7<br>Total<br>Level 4.0 mg/ dL<br>SD= 0.06<br>CV(%)= 1.6<br>Level 8.4 mg/ dL<br>SD=0.12<br>CV(%)= 1.5<br>Level 11.9 mg/ dL<br>SD= 0.18<br>CV(%)= 1.5 | Serum:<br>Within run<br>Level 6.2 mg/dL<br>SD= 0.06<br>CV(%)= 1.0<br>Level 8.5 mg/dL<br>SD=0.17<br>CV(%)= 2.0<br>Level 10.9 mg/dL<br>SD=0.18<br>CV(%)= 1.6<br>Total<br>Level 6.2 mg/dL<br>SD=0.12<br>CV(%)= 2.0<br>Level 8.5 mg/dL<br>SD= 0.21<br>CV(%)=2.4<br>Level 10.9 mg/dL<br>SD= 0.23<br>CV(%)= 2.1<br>Urine:<br>Within run<br>Level 5.8 mg/dL<br>SD= 0.10<br>CV(%)= 1.7<br>Level 12.7 mg/dL<br>SD= 0.08<br>CV(%)=0.6 |
| | | Total |
| | | Level 5.8 mg/dL<br>SD=0.12<br>CV(%)= 2.1<br>Level 12.7 mg/dL<br>SD=0.64<br>CV(%)= 5.1 |
| Method Comparison | Serum (Comparison to Bayer ADVIA 2400): | Serum (comparison to ADVIA 1650): |
| | y = $1.04 x - 0.002$<br>R = 0.994<br>range from 0.44 to 18.25 mg/dL<br>N = 112 | y = $1.01x +0.27$<br>R = 0.988<br>Range: 4.6 - 12.1 mg/dL<br>N = 242 |
| | | Serum (comparison to reference method): |
| | | y = $1.00x - 0.56$<br>R = 0.996<br>Range: 2.5 - 13.9 mg/dL<br>N = 48 |
| | | Urine (comparison to ADVIA 1650): |
| | | y = $0.98x + 0.23$<br>R = 0.999<br>Range: 1.0 - 15.0 mg/dL<br>N = 64 |
| Limitations | Lipemia: | Lipemia (from Intralipid): |
| | No interference found up to 1000<br>mg/dL (10 g/l) of Intralipid. | No significant interference<br>found up to 625 mg/dl of<br>Intralipid. |
| | Hemolysate: | |
| | No interference found up to 1000<br>mg/dl (10 g/l) of hemoglobin | Hemolysate: |
| | | No significant interference<br>found up to 525 mg/dl of<br>hemoglobin. |
| | Bilirubin, conjugated: | |
| | No interference found up to 58<br>mg/dL (1000 µmol/l) of<br>conjugated bilirubin. | Bilirubin: |
| | Bilirubin, unconjugated: | No significant interference<br>found up to 30 mg/dl. |
| | No interference found up to 58<br>mg/dL (1000 µmol/l) of<br>unconjugated bilirubin. | |

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Thermo Fisher Scientific Oy

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

[phone] tel
[phone] fax

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

ww.themo.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 [phone]. 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 [phone] or [phone] 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

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.

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