ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II

K122858 · Elitechgroup · JFJ · Oct 3, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122858
• Device Name: ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
• Applicant: Elitechgroup
• Product Code: JFJ · Clinical Chemistry
• Decision Date: Oct 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Intended Use

ELITech Clinical Systems AMYLASE SL is intended for the quantitative in vitro determination of amylase in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Measurements of amylase are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Device Story

ELITech Clinical Systems AMYLASE SL is an in vitro diagnostic reagent kit for measuring amylase activity in human serum and plasma. The device uses an enzymatic method where the substrate CNP-G3 is hydrolyzed by amylase to produce CNP. The rate of increase in absorbance at 405 nm is measured on ELITech Clinical Systems Selectra analyzers; this rate is directly proportional to amylase activity. The system includes ELICAL 2 (calibrator) and ELITROL I/II (control sera). The device is used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and monitoring pancreatitis. The system provides quantitative data to support clinical decision-making regarding pancreatic inflammation.

Clinical Evidence

Bench testing only. Performance validated per CLSI guidelines (EP5-A2, EP6-A, EP17-A, EP7-A2, EP9-A2). Precision: Total CV% 2.2-2.7%. Linearity: 20-1500 U/L. LoD: 6 U/L; LoQ: 13 U/L. Method comparison (n=100) vs. Roche AMYL2 yielded y = 0.976x - 1, r=0.999. Plasma comparison (n=48) yielded y = 0.907x + 1, r=1.000. No significant interference from bilirubin, triglycerides, hemoglobin, acetaminophen, ascorbic acid, or acetylsalicylic acid at tested concentrations.

Technological Characteristics

Enzymatic assay using CNP-G3 substrate. Reagent composition: MES buffer (pH 6.15), NaCl, CaCl2, potassium thiocyanate, CNP-G3, sodium azide. Lyophilized human serum-based calibrators and controls. Photometric detection at 405 nm. Designed for use on Selectra ProM analyzers. No software algorithm class specified; standard clinical chemistry photometric analysis.

Indications for Use

Indicated for the quantitative in vitro determination of amylase in human serum and plasma to aid in the diagnosis and treatment of pancreatitis. Not for Point of Care use. Prescription use only.

Regulatory Classification

Identification

An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Submission Summary (Full Text)

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122858

# 510(k) Summary

ELITech Clinical Systems AMYLASE SL

| 1. Date: | September 14, 2012 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Submitter: | ELITech Clinical Systems SEPPIM S.A.S<br>Zone Industrielle<br>61500 SEES<br>FRANCE |
| 3. Contact Person: | Debra K. Hutson<br>Director, QARA, North America<br>21720 23rd Dr SE, Suite 150<br>Bothell, WA 98021<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 4. Device Description: | ELITech Clinical Systems AMYLASE SL |
| Classification | Class II<br>JFJ<br>Clinical Chemistry<br>21 CFR 862.1070 |
| Device Description: | ELITech Clinical Systems ELICAL 2 |
| Classification | Class II<br>JIX<br>Clinical Chemistry<br>21 CFR 862.1150 |
| Device Description: | ELITech Clinical Systems ELITROL I and ELITROL II |
| Classification | Class I, reserved<br>JJY<br>Clinical Chemistry |
| 5. Predicate Device: | k063744<br>Roche Diagnostics<br>AMYL2 (α-Amylase EPS ver.)<br>k033501<br>Roche Diagnostics<br>Calibrator for Automated Systems (C.f.a.s.)<br>k041227<br>Roche Diagnostics<br>Precinorm and Precipath |
| 6. Intended Use | |
| Reagents: | ELITech Clinical Systems AMYLASE SL is intended for<br>the quantitative <i>in vitro</i> determination of amylase in human<br>serum and plasma on ELITech Clinical Systems Selectra<br>analyzers. It is not intended for use in Point of Care<br>settings. Measurements of amylase are used primarily for<br>the diagnosis and treatment of pancreatitis (inflammation<br>of the pancreas). |
| Calibrators: | ELITech Clinical Systems ELICAL 2 is a multi-parametric |

OCT 3 2012·

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calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

## Controls:

ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

# Special conditions for use statement(s):

Prescription Use Only. It is not intended for use in Point of Care settings.

# Special instrument requirements:

Performance was provided for the ELITech Clinical Systems Selectra ProM.

## Device Description

ELITech Clinical Systems AMYLASE SL is available as kit only. It consists of one reagent R whose the composition is: MES buffer (pH 6.15), sodium chloride, calcium chloride, potassium thiocyanate, CNP-G3 (2-chloro-4-nitrophenyl-α-maltotrioside), sodium azide.

ELITech Clinical Systems ELICAL2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to the antibodies to HCV and HIV according to FDA-approved methods.

ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of a lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.

#### 8. Substantial Equivalence Information -

#### Assay

- 1. Predicate Device Name
- Roche Diagnostics AMYL2 (a-Amylase EPS ver.)
- 2. k063744
- 3. Comparison with predicate

#### Similarities

| Parameter | AMYLASE SL | Roche Diagnostics AMYL2<br>(α-Amylase EPS ver.) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for the quantitative<br>in vitro determination of<br>amylase in human serum and<br>plasma on ELITech Clinical<br>Systems Selectra analyzers.<br>It is not intended for use in<br>Point of Care settings. | In vitro test for the<br>quantitative determination of<br>amylase in human serum and<br>plasma on the cobas c111<br>system. |
| Specimen Type | Serum, Plasma | Same |
| Assay Technology | Enzymatic method | Same |
| Calibration frequency | 28 days | Same |

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## Differences

| Parameter | AMYLASE SL | Roche Diagnostics AMYL2<br>(α-Amylase EPS ver.) |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Range | Serum/plasma:20 - 1500 U/L | Serum/plasma: 3-1500 U/L |
| Instrument | Selectra ProM analyzer | cobas c111 |
| Calibrator | Recommended calibration<br>material (not included):<br>ELITech Clinical Systems<br>ELICAL 2 | Recommended calibration<br>material (not included):<br>Roche Calibrator f.a.s. |
| Interference | Triglycerides: No significant<br>interference up to 3000<br>mg/dL.<br>Unconjugated bilirubin: No<br>significant interference up to<br>30.0 mg/dL (513 µmol/L).<br>Conjugated bilirubin: No<br>significant interference up to<br>29.5 mg/dL (504 µmol/L).<br>Ascorbic acid: No significant<br>interference up to 20.0<br>mg/dL.<br>Acetaminophen: No<br>significant interference up to<br>30.0 mg/dL.<br>Acetylsalicylic acid: No<br>significant interference up to<br>200.0 mg/dL. | Hemoglobin: No significant<br>interference up to an H Index<br>of 100 (approximate 100<br>mg/dL).<br>Lipemia (Intralipid): No<br>significant influence up to an<br>L index of 1000. Icterus: No<br>significant influence up to I<br>Index of 15 (approximate<br>conjugated and unconjugated<br>bilirubin concentration of 15<br>mg/dL (257µmol/L)). |
| Reference Range | Serum/plasma:1< 31-107 U/L | Serum/plasma: 28-100 U/L |

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¹ Schumann, G., et al., IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37°C, Clin Chem Lab Med, (2006), 44(9), 1146.

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## Control Sera

- 1. Predicate Device Name:
- Roche Diagnostics Precinorm U and Precipath U
- 2. k041227

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- 3. Comparison with predicate

| Similarities and Differences | | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Candidate Device<br>(ELITech Clinical Systems<br>ELITROL I and ELITROLII) | Predicate<br>Roche Diagnostics<br>Precinorm U and Precipath U<br>(k041227) |
| Intended Use/Indications for<br>Use | ELITech Clinical Systems<br>ELITROL I and ELITROL II<br>are multi-parametric control<br>sera for in vitro diagnostic<br>use in quality control of<br>quantitative ELITech<br>Clinical Systems methods on<br>ELITech Clinical Systems<br>Selectra Analyzers. | Precinorm U is for use in quality<br>control by monitoring accuracy<br>and precision for the quantitative<br>methods as specified in the<br>value sheets.<br>Precipath U is for use in<br>quality control by monitoring<br>accuracy and precision for<br>the quantitative methods as<br>specified in the value sheets. |
| Format | Lyophilized human sera with<br>constituents added as<br>required to obtain defined<br>component levels | Same |
| Levels | Two Levels (Level I and<br>Level II) | Same |
| Stability | Lyophilized: Store at 2-8°C<br>and protected from light until<br>the expiry date. After<br>Reconstitution: 12 hours<br>between 15-25°C, 5 days<br>between 2-8°C, 4 weeks<br>between -25 and -15°C<br>(when frozen once) | Same |

## Calibrator

- 1. Predicate Device Name:
- Roche Diagnostics Calibrator for Automated Systems (C.f.a.s)
-
- 2. k033501
3. Comparison with predicate

| Similarities and Differences | | |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Candidate Device<br>(ELITech Clinical Systems<br>ELICAL 2) | Predicate<br>Roche Calibrator for<br>Automated Systems (C.f.a.s.)<br>k033501 |
| Intended Use/Indications for<br>Use | ELITech Clinical Systems<br>ELICAL 2 is a multi-<br>parametric calibrator for <i>in</i><br><i>vitro</i> diagnostic use in the<br>calibration of quantitative<br>ELITech Clinical Systems<br>methods on ELITech Clinical<br>Systems Selectra analyzers. | Calibrator for automated systems<br>(C.f.a.s.) is for use in the<br>calibration<br>of quantitative Roche methods<br>on Roche clinical chemistry<br>analyzers<br>as specified in the value sheets. |

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| Format | Lyophilized calibrator based<br>on human serum with<br>constituents added as<br>requires to obtain desired<br>component levels | Same |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Level | Single Level | Same |
| Stability | Lyophilized: store at 2-8°C<br>and protect from light until the<br>expiry date.<br>After reconstitution: 8 hours<br>between 15-25°C, 2 days<br>between 2-8°C, 4 weeks<br>between -25 and -15°C<br>(when frozen once) | Same |

#### റ്റ. Standard/Guidance Document Reference

- Evaluation of Precision Performance of Quantitative Measurement Methods; . Approved Guideline-Second Edition. CLSI (NCCLS) document EP5-A2, Vol 24, No. 25, August 2004.
- Protocols for Determination of Limits of Detection and Limits of Quantification; . Approved Guideline. CLSI (NCCLS) document EP17-A, vol 24, No. 34, October 2004.
- Method Comparison and Bias estimation Using Patient Samples; Approved . Guideline-Second Edition. CLSI (NCCLS) document EP9-A2-IR, Vol 30, No. 17, July 2010.
- Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices . Intended for Professional Use: Guidance for Industry and FDA Staff, November 2004.
- Interference Testing in Clinical Chemistry; Approved Guideline-Second . Edition. CLSI (NCCLS) document EP07-A2, Vol 25, No. 27, November 2005.
- Evaluation of the Linearity of the Measurement of Quantitative Procedures: a . Statistical Approach; Approved Guideline. CLSI (NCCLS) document EP6-A, Vol 23, No. 16, April 2003.

#### 10. Test Principle:

Enzymatic Method. Substrate CNP-G3 is hydrolyzed by catalitic action of a-amylase to produce CNP (2chloro-4-nitrophenol).

5 CNP-G3 &amylase 3CNP + 2CNP-G2 + 3 Maltotriose + 2 Glucose

CNP-G2 = 2-Chloro-4-nitrophenyl-a-maltoside

The rate of increase in absorbance is measured at 405 nm and is directly proportional to the activity «-amylase in the sample.

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#### Performance Characteristics - Analytical Performance 11.

## a. Precision/Reproducibility

The precision of the device was determined in accordance with Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI (NCCLS) document EP5-A2, Vol 24, No. 25, August 2004.

Within-run and Total precision results were obtained by performing two runs per day. two measures per run, for 3 levels of samples on 2 instruments during twenty operating days according to CLSI EP5-A2 protocol. The results are presented in the table below:

| | n | Mean (U/L) | Within-run SD | Within-run CV% |
|---------|----|------------|---------------|----------------|
| Level 1 | 80 | 82 | 1.07 | 1.3 |
| Level 2 | 80 | 204 | 1.81 | 0.9 |
| Level 3 | 80 | 992 | 14.50 | 1.5 |

#### Within-Run Precision

#### Total Precision

| | n | Mean (U/L) | Total SD | Total CV% |
|---------|----|------------|----------|-----------|
| Level 1 | 80 | 82 | 2.21 | 2.7 |
| Level 2 | 80 | 204 | 4.40 | 2.2 |
| Level 3 | 80 | 992 | 25.36 | 2.6 |

## b. Linearity/assay reportable range

The linearity study of AMYLASE SL reagent was performed according to CLSI protocol EP6-A. From this study, a measuring range from 20 to 1500 U/L has been determined. Manual dilution 1 to 10 allows an upper linearity of AMYLASE SL reagent to 15000 U/L.

#### c. Traceability

For calibration, a multi-parametric calibrator named ELITech Clinical Systems ELICAL 2 (manufactured by SEPPIM under product code CALI-0580) must be used. Its value is traceable to the IFCC method.

## d. Stability

#### Real-time stabilities:

On board stability for the ELITech Clinical Systems AMYLASE SL was established by real time studies on the ELITech Systems Selectra ProM. The on-board stability of the reagent is 28 days. The shelf-life of AMYLASE SL reagent has been followed in the real time for 24 months on 3 different batches.

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Control material is purchased from a commercial vendor (previously cleared under k041227). The following is claimed for stability: Before reconstitution, the shelf-life of the ELITech Clinical Systems Elitrol II is 24 months at 2-8°C. After reconstitution the stability is 12 hours when stored at 15-25°C, 5 days when stored at 2-8°C or 4 weeks (when frozen once) at -25° and -15° C.

Calibrator material is purchased from a commercial vendor (previously cleared under k033501). The following is claimed for stability: Before reconstitution, the shelf-life of ELITech Clinical Systems Elical 2 is stable 24 months at 2-8°C. After reconstitution the stability is 8 hours when stored at 15-25°C, 2 days at 2-8°C or 4 weeks (when frozen once) at -25°and -15°C. The labeling stated that the Elical 2 should be stored tightly capped and protected from light when not in use.

#### Value Assignment

Elitrol I and II are value assigned using multiple Vital Scientific Pro M analyzers. Each sample is tested in triplicate over several days. The target value of Level I and II are the median of the observed values range. After validation of the target value, a confidence range (high and low values) is then calculated.

Elical 2 is tested against predetermined values on multiple Vital Scientific Pro M using the AMYLASE SL reagent and 2 levels of quality control material. The mean analyte value is calculated and a target value is assigned.

#### e. Detection limit

Determined according to CLSI protocol EP17-A (Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline).

Limit of Detection (LoD) of AMYLASE SL obtained from 15 measurements of 4 samples with a low concentration of analyte (approximately 4 x LoB ~ 13 U/L) is 6 U/L.

Limit of Quantification (LoQ) of AMYLASE SL obtained from 15 measurements of 4 samples at nominal concentration 13 U/L is 13 U/L.

#### f. Interference/analytical specificity

Interferences due to unconjugated bilirubin, conjugated bilirubin, triglycerides, hemoglobin, acetaminophen, ascorbic acid, acety|salicylic acid were investigated following the recommended sample levels in CLSI EP7-A2 protocol (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition). The results of testing interferences are the following:

- Concentration up to 30.0 mg/dL unconjugated bilirubin, 29.5 mg/dL unconjugated bilirubin, 3000 mg/dL triglycerides and 500 mg/dL hemoglobin do not show any significant interference for each substance.
- Likewise, concentrations up to 30 mg/dL acetaminophen, 20.0 mg/dL ascorbic acid । and 200 mg/dL acetylsalicylic acid do not show any significant interference for each substance.

#### The following statement will also be included in the labeling:

Other compounds may interfere. Users should refer to the two following literature references:

-Young, D. S., Effects of preanalytical variables on clinical laboratory tests, 200 Ed., AACC Press, (1997).

-Young, D. S., Effects of drugs on clinical laboratory tests, 40 Ed., AACC Press, (1995). -Berth, M. & Delanghe, J. Protein precipitation as a possible important pitfall in the clinical chemistry analysis of blood samples containing monoclonal immunoglobulins: 2

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case reports and a review of literature, Acta Clin Belg, (2004), 59, 263.

#### Performance Characteristics - Comparison Studies 12.

#### a. Method comparison

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A correlation study was performed between AMYLASE SL reagent on a Selectra ProM analyzer and Roche Diagnostics AMYL2 (α-Amylase EPS ver.) reagent on a cobas c111 analyzer according to CLSI EP9-A2 protocol (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).

This study was performed using 100 serum patient samples from 21 to 1439 U/L over a span of 5 days.

Regression analysis of the results yielded the following:

y = 0.976 x -1 U/L r = 0.999 r2 = 0.999 Standard error of the estimate Sy.x = 10 U/L.

#### b. Comparison study: Plasma comparison

48 paired plasma (in lithium heparin samples, ranging from 22 to 1491 U/L, were tested on Selectra ProM analyzer according to CLSI protocol EP9-A2 (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition). Regression analysis of the results yielded the following:

v = 0.907 x + 1 U/L r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 6 U/L.

#### c. Matrix comparison:

Matrix comparison studies were not performed. See serum and plasma method comparison data above (Section 12 a. & b.)

We claim that lithium heparin plasma is an acceptable anticoagulant.

#### d. Expected values/Reference Range

As indicated in the instructions for use for AMYLASE SL, each laboratory should establish and maintain its own reference values. The values given are used as guidelines only.

#### < 31-107 U/L

These values are from "Schumann, G., et al.. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37°C, Clin Chem Lab Med, (2006), 44(9), 1146."

#### d. Clinical Studies:

Not applicable

- e. Clinical Cut-off:
Not applicable

#### 13. Conclusion

The information on the principle and performance of our device that is contained in this premarket notification is complete and supports a decision that our device is substantially equivalent to the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

#### Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

ਹੁੰਦੀ

ELITech Group EPOCH Biosciences c/o Debra K. Hutson, Director, QARA, North America 21720 23rd Dr SE, Suite 150 Bothell, WA 98021

k122858 Re:

> Trade Name: ELITech Clinical Systems AMYLASE SL; ELITech Clinical Systems ELICAL 2; ELITech Clinical Systems ELITROL I and ELITROL II Regulation Number: 21 CFR §862.1070 Regulation Name: Amylase test system. Regulatory Class: Class II Product Codes: JFJ, JIX and JJY Dated: September 14, 2012 Received: September 18, 2012

Dear Ms. Hutson:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

3 2012

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# Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Devices and Radiological Health at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" And, product not regarding regarding postmarket surveillance, please contact CDRH'S Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-576-. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800 638-2041 or [phone] or at its Internet address http://www.fda/gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Ci

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

Enclosure

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# Indications for Use Form

510(k) Number (if known):

ELITech Clinical Systems AMYLASE SL Device Name:

Indications for Use:

ELITech Clinical Systems AMYLASE SL is intended for the quantitative in vitro determination of amylase in human serum and plasma on ELITech Clinical Systems Selectra analyzers.

It is not intended for use in Point of Care settings.

Measurements of amylase are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

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

Yung Chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K122858

Page 1 of 3

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# Indications for Use Form

510(k) Number (if known): k122858

ELITech Clinical Systems ELICAL 2 Device Name:

Indications for Use: .

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems on ELITech Clinical Systems Selectra analyzers.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

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

Yung Chan

Division Sign-(0) Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k122858

Page 2 of 3

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# Indications for Use Form

510(k) Number (if known): k122858

Device Name:

ELITech Clinical Systems ELITROL I ELITech Clinical Systems ELITROL II

Indications for Use:

ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

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

Yung Chan

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

510(k) *k122858*

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