ELECSYS FOLATE III

K141426 · Roche Diagnostics · CGN · Oct 17, 2014 · Clinical Chemistry

Device Facts

• Record ID: K141426
• Device Name: ELECSYS FOLATE III
• Applicant: Roche Diagnostics
• Product Code: CGN · Clinical Chemistry
• Decision Date: Oct 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1295
• Device Class: Class 2

Intended Use

Binding assay for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Folic acid measurements are used in the diagnosis and treatment of anemias.

Device Story

Elecsys Folate III is an in vitro diagnostic immunoassay for human serum folate quantification. It uses a competitive binding principle: folate in the sample competes with biotinylated folate for binding sites on a ruthenium-labeled folate binding protein (FBP). Streptavidin-coated microparticles capture the complex. The device is used on Elecsys and cobas e immunoassay analyzers in clinical laboratory settings. Operation involves automated processing where the analyzer measures electrochemiluminescence signals. Results are calculated via a 2-point calibration and a master curve provided by reagent bar codes. Healthcare providers use these measurements to diagnose and treat anemias. The device benefits patients by providing standardized folate levels to guide clinical management.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (n=84); total CVs ranged 3.7-10.8%. Linearity confirmed 2-20 ng/mL (R²=0.997). LoB 0.64 ng/mL, LoD 1.2 ng/mL, LoQ 2.0 ng/mL. Method comparison against Abbott Architect Folate (n=106) yielded y = 0.976x + 0.041 (r=0.984). Reference range established using 214 healthy adults (4.8-24.2 ng/mL). No clinical diagnostic studies performed.

Technological Characteristics

Competitive immunoassay; ruthenium-labeled folate binding protein; biotinylated folate; streptavidin-coated microparticles. Chemiluminescence detection. Analyzers: Elecsys/cobas e series. Standards: CLSI EP5-A2, EP17-A2, EP6-A, EP-09-A2-IR. Traceability: WHO International Standard NIBSC 03/178. Measuring range: 2.0-20.0 ng/mL.

Indications for Use

Indicated for the quantitative determination of folate in human serum to aid in the diagnosis and treatment of anemias in adult patients. Contraindicated for patients receiving therapy with methotrexate or leucovorin due to cross-reactivity.

Regulatory Classification

Identification

A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.

Predicate Devices

• Roche Elecsys Folate III (k082340)

Reference Devices

• Elecsys Folate II assay (k043318)
• Abbott Architect Folate assay (k092740)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are connected by a curved line that runs from the top of the head of the top profile to the bottom of the chin of the bottom profile. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 17, 2014

ROCHE DIAGNOSTICS KELLI TÜRNER U.S. REGULATORY AFFAIRS PRINCIPAL 9115 HAGUE ROAD INDIANAPOLIS IN 46250-0416

Re: K141426

Trade/Device Name: Elecsys Folate III Regulation Number: 21 CFR 862.1295 Regulation Name: Folic acid test system Regulatory Class: II Product Code: CGN Dated: September 10, 2014 Received: September 11, 2014

Dear Ms. Turner:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Courtney

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) k141426

Device Name Elecsys Folate III

Indications for Use (Describe)

Binding assay for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. Folic acid measurements are used in the diagnosis and treatment of anemias.

#### Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

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# 510(k) Summary for the Elecsys Folate III Assay

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. | | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|--------|
| Submitter<br>Name,<br>Address,<br>Contact | Roche Diagnostics<br>9115 Hague Road<br>P.O. Box 50416<br>Indianapolis, IN 46250-0415 | | |
| | Contact Person: Kelli Turner | | |
| | • | Phone: [phone] | |
| | • | Fax: [phone] | |
| | • | Email: [e-mail] | |
| | Date Prepared: October 9, 2014 | | |
| Purpose | In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits<br>official notification as required by Section 510(k) of the Federal Food, Drug<br>and Cosmetics Act of our intention to market the device described in this<br>Premarket Notification [510(k)]. | | |
| | The purpose of this premarket notification is to obtain FDA review and<br>clearance for the Folate III Assay. | | |
| Device Name | Proprietary name: | Elecsys Folate III Assay | |
| | Common name: | Folate III assay | |
| | Classification name: | Acid, Folic, Radioassay | |
| | Product Code: | CGN | |
| | Predicate Device: | Roche Elecsys Folate III (k082340) | |
| Establishment<br>Registration | For the Elecsys Folate III assay, the establishment registration number for<br>Roche Diagnostics GmbH in Mannheim, Germany, is 9610126 and for<br>Penzberg, Germany, is 9610529. The establishment registration number for<br>Roche Diagnostics in the United States is 1823260 | | |
| Classification | The FDA has classified the Radiometry, Folate III assay as a Class II device. | | |
| Device<br>Description | The Folate III Assay employs a competitive test principle using natural folate<br>binding protein (FBP) specific for folate. Folate in the sample competes with the<br>added folate (labeled with biotin) for the binding sites on FBP (labeled with a<br>ruthenium complex).<br>Results are determined using a calibration curve that is generated specifically on<br>each instrument by a 2 point calibration and a master curve (5-point-calibration)<br>provided with the reagent bar code. | | |
| | Reagents-working<br>solutions | Description | Volume |
| | PT1: Pretreatment<br>reagent 1 | Sodium 2-mercaptoethanesulfonate<br>(MESNA) 40 g/L, pH 5.5 | 4 mL |
| | PT2: Pretreatment<br>reagent 2 | Sodium hydroxide 25 g/L | 5 mL |
| | M: Microparticle | Streptavidin-coated microparticles 0.72<br>mg/mL; preservative | 6.5 mL |
| | R1: Folate binding | Ruthenium labeled folate binding protein | 9 mL |

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protein

R2: Folate~biotin

## 510(k) Summary for Elecsys Folate III Assay, continued

75 µg/mL; human serum albumin (stabilizer); borate/phosphate/citrate buffer 70 mmol/L, pH 5.5; preservative

Biotinylated folate 17 µg/L; biotin 120

borate buffer 100 mmol/L, pH 9.0;

preservative

µg/L; human serum albumin (stabilizer);

Continued on next page

8 mL

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| Intended | Elecsys Folate III: | | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------|--|--|
| Use/ | Binding assay for the in vitro quantitative determination of folate in | | |
| Indications | human serum. The binding assay is intended for use on Elecsys and | | |
| for Use | cobas e immunoassay analyzers. Folic acid measurements are used in<br>the diagnosis and treatment of anemias. | | |
| Substantial<br>Equivalence | The Elecsys Folate III assay is substantially equivalent to other devices<br>legally marketed in the United States. | | |
| | The Elecsys Folate III assay is equivalent to Elecsys Folate III assay<br>(k082340). | | |
| | | | |

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The following table compares the Elecsys Folate III Assay with its predicate Substantial device (k082340). Equivalence -Comparison

#### Comparison of Assays, Similarities and Differences

| Table 1 | |
|---------|--|
|---------|--|

| Assay Comparison | | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Feature | Predicate Device: Roche Elecsys<br>Folate III (k082340) | Candidate Device: Elecsys Folate III Assay |
| General Assay Features | | |
| Intended Use/ Indications for Use | Intended for the in vitro quantitative determination of folate in human serum. The binding assay is intended for use on Elecsys and cobas e immunoassay analyzers. | Same. |
| Assay Protocol | The Elecsys Folate assay employs a competitive test principle using natural folate binding protein (FBP) specific for folate. Folate in the sample competes with the added folate (labeled with biotin) for the binding sites on FBP (labeled with ruthenium). | Same. |
| Detection Protocol | Electrochemiluminescent Assay | Same. |
| Applications | 27-minute application | Same. |
| Instrument Platform | Elecsys and cobas e immunoassay analyzers. | Same. |
| Sample Volume | 25 μL | Same |
| Sample Type | Human serum. | Same. |

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## Comparison of Assays—Similarities and Differences, continued

## Table 1 continued

| Assay Comparison | | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Feature | Predicate Device: Roche Elecsys<br>Folate III (k082340) | Candidate Device: Elecsys Folate<br>III Assay |
| General Assay Features | | |
| Reagents | Competition principle. Total duration<br>of assay: 27 minutes | Same. |
| Calibrator | Elecsys Folate III CalSet | Same. |
| Calibration<br>Interval | Calibration must be performed once<br>per reagent lot using fresh reagent (i.e.<br>not more than 24 hours since the<br>reagent kit was registered on the<br>analyzer). Renewed calibration is<br>recommended as follows:<br>cobas e 411 analyzers:<br>• After 1 month (28 days) when<br>using the same reagent lot.<br>• After 7 days (when using the<br>same reagent kit on the<br>analyzer).<br>As required: e.g. quality control<br>findings outside the specified limits | Same. |
| Controls | Elecsys PreciControl Varia | Same. |
| Traceability<br>/Standardization | Standardized against the Elecsys<br>Folate II assay (k043318) | Standardized against WHO<br>International Standard NIBSC code:<br>03/178. |

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## Comparison of Assays—Similarities and Differences, continued

## Table 1 continued

| Assay Comparison | | | | | | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------|----------------|------------------------------|---------------------------------------|
| Feature | Predicate Device: Roche Elecsys Folate III (k082340) | Candidate Device: Elecsys Folate III Assay | | | | |
| General Assay Features | | | | | | |
| Reagent<br>Stability | Unopened:<br>2-8°C - Up to the stated expiration date<br>Opened 2-8°C - 8 weeks<br>On Analyzers – 2 weeks or 4 weeks<br>when stored alternatively in the<br>refrigerator and on the analyzer, with<br>the toal time on-board the analyzer<br>not exceeding 10x8 hours | Same. | | | | |
| Measuring<br>Range | 1.50- 20.0 ng/mL | 2.0- 20.0 ng/mL | | | | |
| Analytical<br>Sensitivity | Limit of Blank (LoB): = 0.640 ng/mL<br>Limit of Detection (LoD): = 1.50 ng/mL<br>Limit of Quantitation (LoQ): = 2.0 ng/mL | Limit of Blank (LoB): = 0.6 ng/mL<br>Limit of Detection (LoD): = 1.2 ng/mL<br>Limit of Quantitation (LoQ): = 2.0 ng/mL | | | | |
| Analytical<br>Specificity | Cross reactant | concentration tested (ng/mL) | Highest cross-reactivity observed (%) | Cross reactant | concentration tested (ng/mL) | Highest cross-reactivity observed (%) |
| | Amethopterin | 750 | 2.3 | Amethopterin | 1500 | 2.5 |
| | Aminopterin | 750 | 2.7 | Aminopterin | 1500 | 4.4 |
| | Folonic acid | 750 | 2.3 | Folonic acid | 1500 | 0.7 |

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#### Comparison of Assays—Similarities and Differences, continued

#### Table 1 continued

| Assay Comparison | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Feature | Predicate Device: Roche Elecsys<br>Folate III (k082340)<br>Labeled Performance Characteristics | Candidate Device: Elecsys Folate III Assay<br>Labeled Performance Characteristics | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Precision | <i>cobas e 411:</i><br>Within-run Sample Mean SD CV HS 1 4.30 0.157 3.7% HS 2 6.17 0.274 4.4% HS 3 6.83 0.288 4.2% HS 4 15.7 0.620 4.0% PCV1 4.05 0.235 5.8% PCV2 11.8 0.562 4.8%<br>Total Sample Mean SD CV HS 1 4.30 0.383 8.9% HS 2 6.17 0.444 7.2% HS 3 6.83 0.484 7.1% HS 4 15.7 0.956 6.1% PCV1 4.05 0.382 9.4% PCV2 11.8 0.845 7.2% | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | <i>cobas e 411:</i><br>Within-run (will be labeled Repeatability) Sample Mean SD CV HS 1 2.29 0.155 6.8% HS 2 3.92 0.200 5.1% HS 3 11.9 0.346 2.9% HS 4 13.4 0.301 2.2% HS 5 17.8 0.44 2.5% PCV1 3.24 0.215 6.6% PCV2 11.6 0.314 2.7%<br>Total (will be labeled Intermediate) Sample Mean SD CV HS 1 2.29 0.247 10.8% HS 2 3.92 0.318 8.1% HS 3 11.9 0.571 4.8% HS 4 13.4 0.574 4.3% HS 5 17.8 0.67 3.7% PCV1 3.24 0.309 9.5% PCV2 11.6 0.566 4.9% | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

HS= Human Serum PCV1=PreciControl Varia level 1 PCV2=PreciControl Varia level 2

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## Table 1 continued

| Assay Comparison | | |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Predicate Device: Roche Elecsys<br>Folate III (k082340)<br><br>Candidate Device: Elecsys Folate III Assay | |
| Labeled Performance Characteristics | | |
| Limitations | The assay is unaffected by:<br>Bilirubin < 33 mg/dL Lipemia < 1500 mg/dL Biotin < 21 ng/mL Rheumatoid factors < 1000 IU/mL IgG < 1.6 g/dL IgA < 0.4 g/dL In vitro tests were performed on 18<br>commonly used pharmaceuticals and in<br>addition on human erythropoeetin. No<br>interference with the assay was found. Samples with extremely high total<br>protein concentrations (e.g. patients<br>suffering from Waldenstrom's<br>macroglobulinemia) are not for use in<br>this assay. In rare cases, interference due to<br>extremely high titers of antibodies to<br>analyte-specific antibodies, streptavidin<br>or ruthenium can occur. These effects<br>are minimized by suitable test design. It is contraindicated to measure samples<br>of patients receiving therapy with<br>certain pharmaceuticals, e.g.<br>methotrexate or leucovorin, because of<br>the cross-reactivity of folate binding<br>protein with these compounds. For diagnostic purposes, the results should<br>always be assessed in conjunction with<br>RBC folate, the patient's medical history,<br>clinical examination and other findings. | The assay is unaffected by:<br>Bilirubin < 29 mg/dL Lipemia < 1500 mg/dL Biotin < 21 ng/mL Rheumatoid factors < 1000 IU/mL IgG < 1.6 g/dL IgM < 1.0 g/dL IgA < 0.4 g/dL In vitro tests were performed on 16<br>commonly used pharmaceuticals and in<br>addition on human erythropoeetin. No<br>interference with the assay was found. Samples with extremely high total<br>protein concentrations (e.g. patients<br>suffering from Waldenstrom's<br>macroglobulinemia) are not for use in<br>this assay. In rare cases, interference due to<br>extremely high titers of antibodies to<br>analyte-specific antibodies, streptavidin<br>or ruthenium can occur. These effects<br>are minimized by suitable test design. It is contraindicated to measure samples<br>of patients receiving therapy with<br>certain pharmaceuticals, e.g.<br>methotrexate or leucovorin, because of<br>the cross-reactivity of folate binding<br>protein with these compounds. For diagnostic purposes, the results should<br>always be assessed in conjunction with<br>RBC folate, the patient's medical history,<br>clinical examination and other findings. |

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## Comparison of Assays—Similarities and Differences, continued

#### Table 1 continued

| Assay Comparison | | | | | | |
|-----------------------|-----------------------------------------------------------|-----|----------------|--------------------------------------------|-----------|-----------|
| Feature | Predicate Device: Roche Elecsys Folate III (k082340) | | | Candidate Device: Elecsys Folate III Assay | | |
| | Labeled Performance Characteristics | | | | | |
| Reference range study | Country | (N) | Median | 2.5th-97.5th percentile | | |
| | | | nmol/L | ng/mL | nmol/L | ng/mL |
| | USA | 261 | 31.8 | 14.0 | 16.6-59.3 | 7.3-26.1 |
| | Country | (N) | Median | 2.5th-97.5th percentile | | |
| | | | nmol/L | ng/mL | nmol/L | ng/mL |
| | USA | 214 | 26.8 | 11.8 | 10.9-54.9 | 4.78-24.2 |
| Feature | Predicate Device: Abbott Architect Folate assay (k092740) | | | Candidate Device: Elecsys Folate III Assay | | |
| Method Comparison | n = 106<br>Min = 2.08 ng/mL<br>Max = 19.6 ng/mL | | Passing/Bablok | Linear regression | | |
| | Slope | | 0.980 | 0.976 | | |
| | Intercept | | -0.095 | 0.041 | | |
| | Tau/r | | 0.924 | 0.984 | | |
| | Bias at 4 ng/mL | | -0.175 | -0.054 | | |

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| Standard/<br>Guidance<br>Document<br>Reference | In addition to FDA guidance regarding 510(k) submissions, the following<br>standards were used for the performance studies. |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Evaluation of Precision Performance of Quantitative<br>Measurement Methods; Approved Guideline – Second Edition.<br>CLSI document EP5-A2, Volume 24, No. 25, August 2004. |
| | Evaluation of Detection Capability for Clinical Laboratory<br>Measurement Procedures; Approved Guideline- Second Edition.<br>CLSI document EP17-A2, Volume 32, No. 8, June 2012 |
| | Evaluation of the Linearity of Quantitative Measurement<br>Procedures: A Statistical Approach; Approved Guideline. CLSI<br>document EP6-A, Volume 23, No. 16, April 2003. |
| | Method Comparison and Bias Estimation Using Patient Samples;<br>Approved Guideline; Approved Guideline. CLSI document EP-<br>09-A2-IR, Volume 22, No. 19, September 2002 |
| Conclusion | The submitted information in this premarket notification supports a |

substantial equivalence decision. The data supports a safe, effective device which performs as well as or better than the predicate device.