ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK

K060755 · Roche Diagnostics Corp. · CDD · Apr 10, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060755
• Device Name: ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
• Applicant: Roche Diagnostics Corp.
• Product Code: CDD · Clinical Chemistry
• Decision Date: Apr 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Intended Use

The Vitamin B12 assay is a Binding assay for the in vitro quantitative determination of vitamin B12 in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. Elecsys Vitamin B12 CalSet II is used for calibrating the quantitative Elecsys Vitamin B12 assay on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. For use in the verification of the calibration established by the Elecsys Vitamin B12 reagent on Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.

Device Story

The Elecsys Vitamin B12 Test System is an in vitro diagnostic immunoassay used on Roche Elecsys 2010 and MODULAR ANALYTICS E170 analyzers. It utilizes a competitive electrochemiluminescence immunoassay (ECLIA) principle; Vitamin B12 in the patient sample competes with biotin-labeled Vitamin B12 for binding sites on a ruthenium-labeled intrinsic factor complex. The system includes the assay reagent, CalSet II for calibration, and CalCheck for calibration verification. The device is operated by laboratory professionals in clinical settings. Results are determined via an instrument-specific calibration curve generated by 2-point calibration and a master curve provided via reagent barcode. Clinicians use the quantitative Vitamin B12 measurements to diagnose and monitor anemias associated with gastrointestinal malabsorption. The system provides standardized results to assist in clinical decision-making regarding patient nutritional status and anemia management.

Clinical Evidence

Bench testing only. Precision, linearity, and shelf life studies performed to validate impact of NaOH concentration modification. Results documented in product insert.

Technological Characteristics

Competitive electrochemiluminescence immunoassay (ECLIA). Analyte: Vitamin B12. Reagents include ruthenium-labeled intrinsic factor and biotin-labeled Vitamin B12. Platform: Elecsys 2010 and MODULAR ANALYTICS E170. Calibration: 2-point calibration with master curve via barcode. Calibrators/CalCheck: Lyophilized human serum matrix. Connectivity: Automated analyzer integration.

Indications for Use

Indicated for the in vitro quantitative determination of Vitamin B12 in human serum and plasma to aid in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Regulatory Classification

Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Submission Summary (Full Text)

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K060755

# 510(k) Summary - Elecsys Vitamin B12 Test System

| 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, address,<br>contact | Roche Diagnostics<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] | | |
| | Contact person: Randy Johnson | | |
| | Date prepared: March 20, 2006 | | |
| Device name | Proprietary name: | (1) Elecsys Vitamin B12 Immunoassay<br>(2) Elecsys Vitamin B12 CalSet II<br>(3) Elecsys Vitamin B12 CalCheck | |
| | Common name: | (1) Vitamin B12 Assay<br>(2) Vitamin B12 CalSet<br>(3) Vitamin B12 CalCheck | |
| | Classification name: | (1) Radioassay, Vitamin B12<br>(2) Calibrator, Secondary<br>(3) Single (specified) analyte controls (assayed and<br>unassayed). | |

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| Device description | (1) The Elecsys Vitamin B12 Assay employs a competitive test principle using intrinsic factor specific for Vitamin B12. Vitamin B12 in the sample competes with the added Vitamin B12 labeled with biotin for the binding sites on the ruthenium-labeled intrinsic factor complex. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (2) The Elecsys Vitamin B12 CalSet II is a lyophilized product consisting of human serum with added Vitamin B12 in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. |
| | (3) The Elecsys Vitamin B12 CalCheck is a lyophilized product consisting of human serum with added Vitamin B12. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. |
| Intended use | (1) The Vitamin B12 assay is a Binding assay for the in vitro quantitative determination of vitamin B12 in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers. |
| | (2) Elecsys Vitamin B12 CalSet II is used for calibrating the quantitative Elecsys Vitamin B12 assay on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. |
| | (3) For use in the verification of the calibration established by the Elecsys Vitamin B12 reagent on Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers. |

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| Predicate<br>device | The Elecsys Vitamin B12 Test System is equivalent to other devices legally<br>marketed in the United States. We claim equivalence for the following items: |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | For the Vitamin B12 assay and the Vitamin B12 CalSet II:<br>• The original Elecsys Vitamin B12 on the Elecsys 2010 was cleared<br>under K973702.<br>• In 2001 under K961481/A003, the MODULAR ANALYTICS E170<br>analyzer was acknowledged by FDA. |
| | For the Vitamin B12 CalCheck:<br>• The original Elecsys Vitamin B12 CalCheck was cleared under<br>K974383. |

·

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Device comparison (Reagents)

The table below compares the Elecsys Vitamin B12 (K973702) and the Elecsys Vitamin B12 (modified device).

### Substantial equivalence - similarities

| Topic | Elecsys Vitamin B12<br>(K973702) | Elecsys Vitamin B12<br>(Modified Device) |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | REAGENTS | |
| Intended use | Binding assay for the in vitro<br>quantitative determination of vitamin<br>B12 in human serum and plasma. The<br>electrochemiluminescence<br>immunoassay “ECLIA” is intended<br>for use on the Roche Elecsys<br>1010/2010 and MODULAR<br>ANALYTICS E170 (Elecsys module)<br>immunoassay analyzers. | Binding assay for the in vitro<br>quantitative determination of vitamin<br>B12 in human serum and plasma. The<br>electrochemiluminescence<br>immunoassay “ECLIA” is intended<br>for use on the Roche Elecsys 2010 and<br>MODULAR ANALYTICS E170<br>(Elecsys module) immunoassay<br>analyzers. |
| Assay Protocol | Competitive assay | Same |
| Detection Protocol | Electrochemiluminescence<br>immunoassay | Same |
| Measuring range | 30 -2,000 pg/mL | Same |
| Analytical<br>sensitivity<br>(lower detection<br>limit) | 30 pg/mL | Same |

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Device comparison (Calibrators) The table below compares the Elecsys Vitamin B12 CalSet (K973702) and the Elecsys Vitamin B12 CalSet II (modified device).

### Substantial equivalence - similarities

| Topic | Elecsys Vitamin B12 CalSet<br>(K973702) | Elecsys Vitamin B12 CalSet II<br>(Modified Device) | | |
|--------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| CALIBRATORS | | | | |
| Intended use | Elecsys B12 CalSet is used for<br>calibrating the quantitative Elecsys B12<br>assay on the Elecsys 2010<br>immunoassay system. | Elecsys Vitamin B12 CalSet II is used<br>for calibrating the quantitative Elecsys<br>Vitamin B12 assay on the Elecsys 2010<br>and MODULAR ANALYTICS E170<br>immunoassay analyzers. | | |
| Levels | Two | Same | | |

Continued on next page

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Device The table below compares the Elecsys Vitamin B12 CalCheck (K974383) and comparison the Elecsys Vitamin B12 CalCheck (modified device). (CalCheck)

and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the comments of the contribution of the contribution o

#### Substantial equivalence - similarities

| Topic | Elecsys Vitamin B12 CalCheck<br>(K974383) | Elecsys Vitamin B12 CalCheck<br>(Modified Device) | | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| CALIBRATION VERIFICATION | | | | |
| Intended use | For use in the verification of the<br>calibration established by the Elecsys<br>Vitamin B12 reagent and CalSet on the<br>Elecsys 2010 immunoassay analyzer. | For use in the verification of the<br>calibration established by the Elecsys<br>Vitamin B12 reagent on Elecsys 2010<br>and MODULAR ANALYTICS E170<br>immunoassay analyzers. | | |
| Levels | Three | Same | | |

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Device comparison (Reagents)

The table below compares the differences between the Elecsys Vitamin B12 (K973702) and the Elecsys Vitamin B12 (modified device).

### Substantial equivalence - differences

| Topic | Elecsys Vitamin B12<br>(K973702) | Elecsys Vitamin B12<br>(Modified Device) |
|----------------------------------------------|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| REAGENTS | | |
| Quality<br>control | Elecsys PreciControl Universal | Elecsys PreciControl Anemia 1, 2 and 3 |
| Formulation<br>(PT2) | Composition of PT2: | Composition of PT2: |
| | 36 g/L NaOH (0.9 M) | 40 g/L NaOH (1.0M) |
| Specimen<br>collection<br>and<br>preparation | No additional statement was provided. | A note was added to this section:<br><br>Note: Samples with extremely high<br>total protein concentrations (e.g.<br>patients suffering from Waldenstrom's<br>macroglulinemia) are not suitable for<br>use in this assay, since they may lead<br>to the formation of protein gel in the<br>assay cup. Processing protein gel may<br>cause a run abort. The critical protein<br>is dependent upon the individual<br>sample composition. The formation of<br>protein gel was seen in samples<br>(spiked with human IgG or human<br>serum albumin) having a total protein<br>concentration of > 160 g/L. |

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Device comparison (Reagents),

The table below compares the differences between the Elecsys Vitamin B12 (K973702) and the Elecsys Vitamin B12 (modified device).

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

continued

Substantial equivalence – differences

| Topic | Elecsys Vitamin B12<br>(K973702) | | Elecsys Vitamin B12<br>(Modified Device) | |
|-----------|----------------------------------|-------------|------------------------------------------|-------------|
| | REAGENTS | | | |
| Precision | Elecsys 2010 | | Elecsys 2010 | |
| | Within-Run: | | Within-Run: | |
| | Human Serum 1: 6.9% | 203 pg/mL | HS 1: 8.7% | 232 pg/mL |
| | Human Serum 2: 4.2% | 481 pg/mL | HS 2: 4.4% | 818 pg/mL |
| | Human Serum 3: 2.7% | 1,499 pg/mL | HS 3: 3.0% | 1,245 pg/mL |
| | Control 1: 2.8% | 1,119 pg/mL | PCA 1: 8.3% | 226 pg/mL |
| | Control 2: 4.3% | 471 pg/mL | PCA 2: 4.0% | 610 pg/mL |
| | | | PCA 3: 3.1% | 1,369 pg/mL |
| | Total: | | Total: | |
| | Human Serum 1: 7.6% | 203 pg/mL | HS 1: 9.5% | 232 pg/mL |
| | Human Serum 2: 4.4% | 481 pg/mL | HS 2: 5.1% | 818 pg/mL |
| | Human Serum 3: 3.2% | 1,499 pg/mL | HS 3: 3.7% | 1,245 pg/mL |
| | Control 1: 3.2% | 1,119 pg/mL | PCA 1: 8.0% | 226 pg/mL |
| | Control 2: 4.6% | 471 pg/mL | PCA 2: 5.2% | 610 pg/mL |
| | | | PCA 3: 3.4% | 1,369 pg/mL |
| | MODULAR ANALYTICS E170 | | MODULAR ANALYTICS E170 | |
| | Within-Run: | | Within-Run: | |
| | Human Serum 1: 2.4% | 155 pg/mL | HS 1: 1.2% | 267 pg/mL |
| | Human Serum 2: 2.8% | 359 pg/mL | HS 2: 2.9% | 887 pg/mL |
| | Human Serum 3: 0.6% | 1,162 pg/mL | HS 3: 1.5% | 1,308 pg/mL |
| | PreciControl U1: 0.9% | 667 pg/mL | PCA 1: 1.7% | 308 pg/mL |
| | PreciControl U2: 4.3% | 399 pg/mL | PCA 2: 1.0% | 710 pg/mL |
| | | | PCA 3: 0.8% | 1,524 pg/mL |
| | Total: | | Total: | |
| | Human Serum 1: 6.1% | 157 pg/mL | HS 1: 8.4% | 269 pg/mL |
| | Human Serum 2: 3.6% | 349 pg/mL | HS 2: 3.3% | 853 pg/mL |
| | Human Serum 3: 2.2% | 1,128 pg/mL | HS 3: 2.5% | 1,261 pg/mL |
| | PreciControl 1: 2.8% | 671 pg/mL | PCA 1: 7.5% | 239 pg/mL |
| | PreciControl 2: 4.2% | 391 pg/mL | PCA 2: 3.7% | 658 pg/mL |
| | | | PCA 3: 2.4% | 1,415 pg/mL |

{8}------------------------------------------------

Device comparison (Reagents), continued

The table below compares the differences between the Elecsys Vitamin B12 (K973702) and the Elecsys Vitamin B12 (modified device).

#### Substantial equivalence - differences

| Topic | Elecsys Vitamin B12<br>(K973702) | Elecsys Vitamin B12<br>(Modified Device) |
|----------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | REAGENTS | |
| Method<br>comparison | Comparison of the Elecsys Vitamin B12<br>(y) with a commercially available<br>radiobinding Vitamin B12 assay (x): | Comparison of the Elecsys Vitamin B12<br>assay MODULAR ANALYTICS E170<br>calibrated with the Elecsys Vitamin<br>B12 CalSet(x) versus the MODULAR<br>ANALYTICS E170 calibrated with the<br>Elecsys Vitamin B12 CalSet II (y): |
| | N = 345 | N = 101 |
| | Passing Bablok:<br>$y = -9.2 + 1.06x$<br>r = 0.977<br>SD(md68) = 45.7 | Passing Bablok:<br>$y = 0.982x - 0.018$<br>r = 0.977<br>SD(md68) = 8.05 |
| | Linear regression:<br>$y = 7.4 +1.02x$<br>r = 0.977<br>Sy.x = 75.5 | Linear regression:<br>$y = 0.968x + 5.77$<br>r = 0.999<br>Sy.x = 9.63 |
| | Sample concentrations range:<br>30 - 1,798 pg/mL | Sample concentration range:<br>49 - 1,691 pg/mL |

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The table below compares the differences between the Elecsys Vitamin B12 Device comparison (K973702) and the Elecsys Vitamin B12 (modified device). (Reagents), continued

### Substantial equivalence - differences

| Topic | Elecsys Vitamin B12<br>(K973702) | Elecsys Vitamin B12<br>(Modified Device) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| REAGENTS | | |
| Traceability | Elecsys Vitamin B12 has been<br>calibrated against a commercially<br>available radiobinding Vitamin B12<br>assay. | This method has been standardized<br>against the Elecsys Vitamin B12 assay. |
| Stability | Unopened at 2 - 8°C:<br>Up to the stated expiration date<br><br>After opening:<br>12 weeks at 2 - 8°C<br>On E170/Elecsys 2010:<br>8 weeks | Unopened at 2 - 8°C:<br>Up to the stated expiration date<br><br>After opening at 2 - 8°C:<br>12 weeks<br>On Elecsys 2010:<br>5 weeks<br>On MODULAR ANALYTICS E170:<br>5 weeks |
| Expected values | Normal range<br>United States:<br>243 – 894 pg/mL<br><br>Europe:<br>197 - 866 pg/mL | Normal range:<br>United States:<br>211 – 946 pg/mL<br><br>Europe:<br>191 – 663 pg/mL |
| Calibration<br>verification | Not necessary. The analyzer's<br>software automatically checks the<br>validity of the curve and draws<br>attention to any deviations. | Section deleted. |

{10}------------------------------------------------

Device The table below compares the differences between the Elecsys Vitamin B12 comparison CalSet (K973702) and the Elecsys Vitamin B12 CalSet II (modified device). (Calibrator)

### Substantial equivalence - differences

| Topic | Elecsys Vitamin B12 CalSet<br>(K973702) | Elecsys Vitamin B12 CalSet II<br>(Modified Device) |
|-------------------------|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| | CALIBRATOR | |
| Platform | To be used on the Elecsys 2010<br>immunoassay analyzer. | To be used on Elecsys 2010 and the<br>MODULAR ANALYTICS E170<br>immunoassay analyzers. |
| Matrix | Human serum albumin with added<br>Vitamin B12 | Human serum with added Vitamin B12 |
| Storage form | Liquid | Lyophilized |
| Filling volume | 1.5 mL | 1.0 mL |
| Concentration<br>ranges | Cal 1: approximately 100 pg/mL<br>Cal 2: approximately 1,500 pg/mL | Cal 1: approximately 250 pg/mL<br>Cal 2: approximately 1,500 pg/mL |
| Stability | Unopened at 2 - 8°C:<br>Up to the stated expiration date | Unopened at 2 - 8°C:<br>Up to the stated expiration date |
| | After opening:<br>12 weeks at 2 - 8°C | After reconstitution:<br>At 2 - 8°C: 3 days<br>At -20°C: 3 months (freeze only<br>once) |
| | On the analyzer:<br>Up to 5 hours in total | On the analyzer at 20 - 25°C:<br>Use only once. |
| Traceability | None listed in the package insert. | The Elecsys Vitamin B12 assay (Cat.<br>No. 04745736) has been standardized<br>against the Elecsys Vitamin B12 assay<br>(Cat. No. 11820753). |

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Device The table below compares the differences between the Elecsys Vitamin B12 comparison CalCheck (K974383) and the Elecsys Vitamin B12 CalCheck (modified (Calibration device). verification)

### Substantial equivalence - differences

| Topic | Elecsys Vitamin B12 CalCheck<br>(K974383) | Elecsys Vitamin B12 CalCheck<br>(Modified Device) |
|--------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| CALIBRATION VERIFICATION | | |
| Platform | To be used on the Elecsys 2010<br>immunoassay analyzer. | To be used on the Elecsys 2010 and<br>the MODULAR ANALYTICS E170<br>immunoassay analyzer. |
| Matrix | Buffer matrix with added human<br>serum albumin. | Human serum matrix |
| Storage | Liquid | Lyophilized |
| Fill Volume | 1.9 mL | 1.0 mL |
| Target<br>concentration | Level 1: Approximately 150 pg/mL<br>Level 2: Approximately 875 pg/mL<br>Level 3: Approximately 1,600 pg/mL | Level 1: ≤ 300 pg/mL<br>Level 2: Same<br>Level 3: Same |
| Traceability | None listed in the package insert. | This method has been standardized<br>against the Elecsys Vitamin B12 assay. |
| Stability | Store unopened at 2 - 8°C:<br>Up to the printed expiration date on<br>the bottle labels. | Store unopened at 2 - 8°C:<br>Up to the printed expiration date on<br>the bottles labels. |
| | Stability opened:<br>5 hours at 20-25°C | Stability reconstituted:<br>4 hours at 20-25°C |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### APR 1 0 2006

Mr. Randy J. Johnson M.T. (ASCP), Regulatory Affairs Consultant Roche Diagnostics Corp. 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457

Re: k060755

> Trade/Device Name: Elecsys Vitamin B12 Immunoassay, Calset II and Cacheck Regulation Number: 21 CFR§862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Code: CDD, JIT, JJX Dated: March 20, 2006 Received: March 21, 2006

Dear Mr. Johnson:

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).

{13}------------------------------------------------

#### 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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto G.

Alberto Gutierrez, Ph.D. 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): _K060755

Device Name: Elecsys Vitamin B12 Assay

Indications For Use:

Binding assay for the in vitro quantitative determination of vitamin B12 in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

A Vitamin B12 test system is a device intended to measure Vitamin B12 in serum, plasma. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Prescription Use XXXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

CAC
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K060755

{15}------------------------------------------------

### Indications for Use

510(k) Number (if known): K060755

Device Name: Elecsys Vitamin B12 CalSet II

Indications For Use:

Elecsys Vitamin B12 CalSet II is used for calibrating the quantitative Elecsys Vitamin B12 assay on the Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.

Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vit · Diagnostic Device Evaluation and Safety

060755

{16}------------------------------------------------

### Indications for Use

### 510(k) Number (if known): _K060755

Device Name: Elecsys Vitamin B12 CalCheck

Indications For Use:

ﺮ ﺍﻟﻤﺮﺍﺟﻊ

For use in the verification of the calibration established by the Elecsys Vitamin B12 reagent on Elecsys 2010 and MODULAR ANALYTICS E170 immunoassay analyzers.

Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Viro Diagnostic Device . Evaluation and Safety

K06075T