ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL

K073191 · Thermofisher Scientific OY · CJE · Feb 28, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073191
• Device Name: ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL
• Applicant: Thermofisher Scientific OY
• Product Code: CJE · Clinical Chemistry
• Decision Date: Feb 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Intended Use

Alkaline Phosphatase (IFCC): The Alkaline Phosphatase test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme Alkaline Phosphatase in serum and plasma on T60 instrument according to the IFCC method. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver and bone diseases. For in vitro diagnostic use in the quantitative determination of alkaline phosphatase (orthophosphoric - monoester phospho-hydrolase, alkaline optimum, EC 3.1.3.1) activity in human serum or plasma on T60 instruments according to the IFCC method. eCal For in vitro diagnostic use on T60 instrument. eCal is used as a calibrator for enzyme tests 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.

Device Story

Reagent kit for quantitative colorimetric/enzymatic determination of alkaline phosphatase activity; utilizes T60/T60i clinical chemistry instruments. Input: human serum or plasma samples. Principle: ALP catalyzes hydrolysis of p-nitrophenylphosphate (p-NPP) to p-nitrophenol; product formation measured via absorbance at 405 nm. Output: quantitative enzyme activity (U/L). Used in clinical laboratories; operated by trained personnel. Results assist clinicians in diagnosing/monitoring liver and bone disorders. Includes lyophilized calibrator (eCal) and controls (Nortrol, Abtrol) for quality assurance.

Clinical Evidence

Bench testing only. Performance validated via precision studies (20-day protocol, CV% 0.7-3.7%), linearity (9.4-1215 U/L and extended range up to 10,000 U/L), and interference testing (no interference from lipemia, hemoglobin, or bilirubin). Method comparison against predicate (n=159) showed high correlation (r=0.997, slope 1.003). No clinical studies performed.

Technological Characteristics

In vitro diagnostic reagent system. Principle: Kinetic colorimetric assay (IFCC method). Energy source: Photometric (405 nm). Form factor: Liquid reagents for automated clinical chemistry analyzers (T60). Traceability: Molar absorbance coefficient of p-nitrophenol. Storage: 2-8°C.

Indications for Use

Indicated for quantitative in-vitro diagnostic determination of alkaline phosphatase activity in human serum or plasma to aid in the diagnosis and treatment of liver and bone diseases. For use on T60 and DPC T60i instruments. Prescription use only.

Regulatory Classification

Identification

An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Predicate Devices

• Bayer ADVIA Alkaline Phosphatase (ALPAMP) assay (K991576)

Submission Summary (Full Text)

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## 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

The assigned 510(k) number is:

## Introduction: A.

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.

| B. | Submitter's information | | |
|----|-------------------------|------------------------------------------------|--|
| | 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: | February 13th, 2008 | |
| C. | Device name | | |
| | Proprietary name: | Alkaline Phosphatase (IFCC) plus, codes 981832 | |
| | | and 981833 | |
| | Common name: | Alkaline Phosphatase (IFCC) | |
| | Classification: | Clinical Chemistry | |
| | Class: | II | |
| | Product Code: | CJE | |
| | Proprietary name: | eCal, code 981830 | |
| | Common Name: | Calibrator, Multi-Analyte Mixture | |
| | Classification: | Clinical Chemistry | |
| | Class: | II | |
| | Product Code: | JIX | |
| | Proprietary name: | Nortrol, code 981043 | |
| | Common Name: | Multi-analyte Controls (Assayed and unassayed) | |
| | Classification: | Clinical Chemistry | |
| | Class: | I | |
| | Product Code: | JJY | |
| | Proprietary name: | Abtrol, code 981044 | |
| | Common Name: | Multi-analyte Controls (Assayed and unassayed) | |
| | Classification: | Clinical Chemistry | |
| | Class: | I | |
| | Product Code: | JJY | |
| | | | |

Thermo Fisher Scientific Oy

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

[phone] tel [phone] fax Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki

www.thermo.com

183 28

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### D. Intended Use

Alkaline Phosphatase (IFCC)

For in vitro diagnostic use in the quantitative determination of alkaline phosphatase (orthophosphoric - monoester phospho-hydrolase, alkaline optimum, EC 3.1.3.1) activity in human serum or plasma on T60 instruments according to the IFCC method.

## eCal

For in vitro diagnostic use on T60 instrument. eCal is used as a calibrator for enzyme tests 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.

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

[phone] tel [phone] fax Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki

ww.thermo.com

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#### Indications for use E.

The Alkaline Phosphatase test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme Alkaline Phosphatase in serum and plasma on T60 instrument according to the IFCC method. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver and bone diseases.

For eCal Calibrator, Nortrol and Abtrol see intended use.

#### Substantial Equivalence F.

Bayer Corporation, model Bayer ADVIA 2400 Chemistry System.

Bayer Corporation item: Bayer ADVIA Alkaline Phosphatase (ALPAMP) assay.

#### Substantial equivalence -similarities G.

Alkaline Phosphatase (IFCC) Plus is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Bayer ADVIA Alkaline Phosphatase (ALPAMP) assay (K991576).

Thermo Fisher Scientific Oy

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

[phone] tel [phone] fax Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki

www.themo.com

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The following table compares the Alkaline Phosphatase 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<br>alkaline phosphatase<br>(orthophosphoric - monoester<br>phospho-hydrolase, alkaline<br>optimum, EC 3.1.3.1) activity in<br>human serum or plasma on T60<br>instruments according to the IFCC<br>method (1). | For <i>in vitro</i> diagnostic use in<br>the quantitative determination<br>of alkaline phosphatase in<br>human serum or plasma on the<br>ADVIA Chemistry systems.<br>Such measurements are used<br>in the diagnosis and treatment<br>of hepatobiliary and bone<br>disease. |
| Indication for Use | The Alkaline Phosphatase test<br>system is intended for quantitative<br><i>in-vitro</i> diagnostic determination<br>of the activity of the enzyme<br>Alkaline Phosphatase in serum<br>and plasma on T60 instrument<br>according to the IFCC method.<br>Measurements of alkaline<br>phosphatase are used in the<br>diagnosis and treatment of liver<br>and bone diseases. | See intended use. |
| Assay Protocol | ALP catalyzes the hydrolysis of<br>p-nitrophenylphosphate. The<br>formation of p-nitrophenol in<br>alkaline solution is followed at<br>405 nm. | Alkaline phosphatase<br>hydrolyzes pNPP substrate to<br>form p-nitrophenol. The<br>reaction is<br>followed by the colorimetric<br>measurement of the rate of<br>formation of p-nitrophenol at<br>410/478 nm, which is<br>proportional to the alkaline<br>phosphatase activity. |
| Traceability/Standar<br>dization | The Alkaline Phosphatase (IFCC)<br>Plus method is traceable to the<br>molar absorbance coefficient of p-<br>nitrophenol. | The ADVIA Alkaline<br>Phosphatase (ALPAMP)<br>method standardization is<br>traceable to the IFCC<br>reference method via patient<br>sample correlation. |
| Sample Type | Serum, plasma (Li-heparin) | Serum, plasma (Li-heparin) |
| Reagent Storage | Reagents in unopened vials are<br>stable at 2...8 °C until the<br>expiration date printed on the | Unopened reagents are stable<br>until the expiration date<br>printed on the |
| Thermo Fisher Scientific Oy | Ratastie 2<br>P.O. Box 100<br>FIN-01621 Vantaa<br>Finland | [phone] tel<br>[phone] fax |
| Attribute | New device #1 | Predicate device #1 |
| | label when protected from light. | product label when stored at<br>2° - 8°C. |
| Expected Values | Male: 53 - 128 U/l (0.9 - 2.18<br>µkat/l) at 37 °C<br>Female: 42 - 98 U/l (0.71 - 1.67<br>µkat/l) at 37 °C | 45-129 U/L |
| Instrument | T60 and DPC T60i, DPC T60i<br>Kusti | ADVIA® 2400 Chemistry<br>system. |
| Measuring Range | 20 - 1000 U/L | 0-1100 U/L |
| Attribute | New device #1 | Predicate device #1 |
| Precision | Within run | Within run |
| | Level 91 U/l<br>SD= 0.7<br>CV(%)= 0.7 | Level 68 U/l<br>SD= 0.9<br>CV(%)= 1.3 |
| | Level 127 U/l<br>SD=0.9<br>CV(%)=0.7 | Level 148 U/l<br>SD=2.1<br>CV(%)= 1.4 |
| | Level 374 U/l<br>SD= 2.0<br>CV(%)=0.5 | Total |
| | Level 41 U/l<br>SD= 0.5<br>CV(%)= 1.1 | Level 68 U/l<br>SD= 2.2<br>CV(%)= 3.2 |
| | Level 810 U/l<br>SD= 6.6<br>CV(%)=0.8 | Level 148 U/l<br>SD= 3.8<br>CV(%)= 2.6 |
| | Between run | |
| | Level 91 U/l<br>SD= 0.8<br>CV(%)=0.9 | |
| | Level 127 U/l<br>SD= 1.1<br>CV(%)=0.9 | |
| | Level 374 U/l<br>SD= 2.0<br>CV(%)=0.5 | |
| | Level 41 U/l<br>SD= 1.4<br>CV(%)= 3.5 | |
| | Level 810 U/l<br>SD= 2.5<br>CV(%)=0.3 | |
| | Total | |
| | Level 91 U/l<br>SD= 2.9<br>CV(%)= 3.2 | |
| | Level 127 U/l<br>SD= 2.6<br>CV(%)= 2.0 | |
| | Level 374 U/l<br>SD= 8.4<br>CV(%)=2.3 | |
| | Level 41 U/l<br>SD= 1.5<br>CV(%)= 3.7 | |
| | Level 810 U/l<br>SD= 18.5<br>CV(%)= 2.3 | |
| Thermo Fisher Scientific Oy | Ratastie 2<br>P.O. Box 100 | Y-tunnus 0921547-0<br>VAT NO FI09215470<br>www.thermo.com |
| | [phone] tel<br>[phone] fax | Domicile Helsinki |
| Attribute | New device #1 | Predicate device #1 |
| Method Comparison | $y = 1.023x - 1.61$<br>$R = 0.998$<br>range from 14 to 1752 U/l<br>N = 154 | Comparison with Advia 1650<br>(serum):<br>$y = 1.00x + 1.1$<br>$r = 0.998$<br>$n = 402$<br>range: 26 to 693 U/l |
| | | Comparison with reference<br>method (serum):<br>$y = 1.04x - 14.6$<br>$r = 0.998$<br>$n = 96$<br>range: 49 to 1050 U/l |
| Limitations | Lipemia:<br>No interference found up to 1000<br>mg/dL (10 g/l) of Intralipid. | Lipemia (from Intralipid):<br>No significant interference<br>found up to 500 mg/dl of<br>Intralipid. |
| | Hemolysate:<br>No interference found up to 300<br>mg/dl (3 g/l) of hemoglobin | Hemolysate:<br>No significant interference<br>found up to 500 mg/dl of<br>hemoglobin. |
| | Bilirubin, conjugated:<br>No interference found up to 58<br>mg/dL (1000 µmol/l) of<br>conjugated bilirubin. | Bilirubin:<br>No significant interference<br>found up to 25 mg/dl. |
| | Bilirubin, unconjugated:<br>No interference found up to 21<br>mg/dl (360 µmol/l) of<br>unconjugated bilirubin. | |

:

·

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Image /page/4/Picture/0 description: The image contains the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are stacked on top of the word "SCIENTIFIC". The font is bold and black.

Thermo Fisher Scientific Oy

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

[phone]el
[phone] fax

Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki

www.thermo.com

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# ThermoFisher
S C I E N T I F I C

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Thermo Fisher Scientific Oy

.

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

[phone] tel
[phone] fax

Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki

www.thermo.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like bird symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 28 200

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

k073191 Re: Trade Name: Alkaline Phosphatase (IFCC) Plus, Ecal, Nortrol, Abtrol Regulation Number: 21 CFR 862.1050 : Regulation Name: Alkaline phosphatase or isoenzymes test system. Regulatory Class: Class II Product Codes: CJE, JIX, JIY Dated: February 06, 2008 Received: February 06, 2008

Dear Ms. 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.

Yean 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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# Indication for Use

510(k) Number (if known): K073191

Device Name:

Alkaline Phosphatase (IFCC) Plus, eCal, Nortrol, Abtrol

Indication For Use:

The Alkaline Phosphatase test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme Alkaline Phosphatase in serum and plasma on T60 instrument according to the IFCC method.

Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver and bone diseases

For in vitro diagnostic use on T60 instrument. eCal is used as a calibrator for enzyme tests 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 (OVD)

Signature

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

510(k) k073191