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).

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

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.

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.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied by Predicate/Guidelines)	Reported Device Performance (ELITech Clinical Systems AMYLASE SL)
Precision
Within-run CV%	Not explicitly stated, but generally <5% for clinical chemistry	Level 1: 1.3% Level 2: 0.9% Level 3: 1.5%
Total CV%	Not explicitly stated, but generally <10% for clinical chemistry	Level 1: 2.7% Level 2: 2.2% Level 3: 2.6%
Linearity/Assay Reportable Range	Assay range of predicate: 3-1500 U/L	Serum/plasma: 20-1500 U/L (up to 15000 U/L with 1:10 manual dilution)
Stability (On-board reagent)	Shelf-life for predicate reagents is typically 28 days on-board	28 days
Stability (Shelf-life of reagent kit)	Predicate's shelf-life is typically 12-24 months	24 months
Stability (Reconstituted controls)	Predicate's reconstituted stability is typically 12 hrs at 15-25°C, 5 days at 2-8°C, 4 weeks at -25°C to -15°C	12 hours at 15-25°C, 5 days at 2-8°C, 4 weeks at -25°C to -15°C (when frozen once)
Stability (Reconstituted calibrators)	Predicate's reconstituted stability is typically 8 hrs at 15-25°C, 2 days at 2-8°C, 4 weeks at -25°C to -15°C	8 hours at 15-25°C, 2 days at 2-8°C, 4 weeks at -25°C to -15°C (when frozen once)
Detection Limit (LoD)	Not explicitly stated, but lower than relevant clinical values	6 U/L
Quantification Limit (LoQ)	Not explicitly stated, but lower than relevant clinical values	13 U/L
Interference	No significant interference from common substances within specified concentrations	No significant interference from Triglycerides (up to 3000 mg/dL), Unconjugated bilirubin (up to 30.0 mg/dL), Conjugated bilirubin (up to 29.5 mg/dL), Ascorbic acid (up to 20.0 mg/dL), Acetaminophen (up to 30.0 mg/dL), Acetylsalicylic acid (up to 200.0 mg/dL). Hemoglobin interference not explicitly mentioned in the AMYLASE SL interference section, but a similar criterion for the predicate was mentioned (up to 100 mg/dL).
Method Comparison (Correlation with predicate)	Strong correlation (r > 0.975) and acceptable bias (slope close to 1, intercept close to 0)	y = 0.976 x -1 U/L; r = 0.999; r2 = 0.999; Sy.x = 10 U/L
Plasma Comparison (Correlation with serum)	Strong correlation (r > 0.975) and acceptable bias (slope close to 1, intercept close to 0)	y = 0.907 x + 1 U/L; r = 1.000; r2 = 1.000; Sy.x = 6 U/L

2. Sample Size Used for the Test Set and Data Provenance

Precision Test Set: 80 measurements for each of 3 levels (total of 240 measurements) were taken.
Linearity Test Set: The number of samples for the linearity study is not specified, but the study was conducted according to CLSI protocol EP6-A.
Detection Limit (LoD & LoQ) Test Set: 15 measurements for each of 4 samples with low concentration of analyte (total 60 measurements)
Interference Test Set: The number of unique samples is not specified, but various substances were tested at specified concentrations.
Method Comparison Test Set: 100 serum patient samples.
Plasma Comparison Test Set: 48 paired plasma (in lithium heparin) samples.
Data Provenance: The document does not explicitly state the country of origin. The studies appear to be prospective analytical performance studies conducted by the device manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For in vitro diagnostic devices like the ELITech Clinical Systems AMYLASE SL, "ground truth" for analytical performance studies is typically established by comparing results to well-defined reference methods, predicate devices, or by preparing samples with known concentrations. The document does not mention the involvement of "experts" in the context of establishing ground truth in the way it might apply to image-based diagnostic AI. Instead, it relies on established laboratory procedures and reference standards.
The "IFCC method" is mentioned as the traceability standard for the calibrator, which implies a highly standardized and internationally recognized reference for amylase measurement. The reference range also cites a publication by G. Schumann et al. on IFCC Primary Reference Procedures.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for qualitative or semi-quantitative diagnostic tests where human interpretation is involved. For this quantitative in vitro diagnostic device, such an adjudication method is not relevant or mentioned. The performance is assessed by comparing quantitative results to reference methods, predicate devices, or known values, which is inherently objective and does not require adjudication in the human interpretative sense.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for image-based diagnostics or other tests heavily reliant on human interpretation, often to quantify the improvement in human reader performance with AI assistance. This device is a quantitative clinical chemistry assay, not an AI-assisted diagnostic.

6. Standalone Performance Study

Yes, the performance characteristics (precision, linearity, detection limits, interference, method comparison) described are all standalone (algorithm only) performance studies of the device (AMYLASE SL reagent on the Selectra ProM analyzer). The device itself is an automated assay, and its performance is evaluated independent of human interpretation or intervention beyond standard laboratory procedures.

7. Type of Ground Truth Used

Precision: Internal controls and samples with known or characterized concentrations.
Linearity: Samples prepared with varying, known concentrations.
Traceability: Traceable to the IFCC method.
Stability: Measured over time using internal controls and reference materials.
Detection Limit (LoD) & Quantification Limit (LoQ): Calculated based on repeated measurements of low-concentration samples.
Interference: Samples spiked with known interferents at specified concentrations.
Method Comparison: Comparison against a legally marketed predicate device (Roche Diagnostics AMYL2 on cobas c111 analyzer) using patient samples. This serves as a comparative ground truth.
Plasma Comparison: Comparison between serum and lithium heparin plasma samples from the same patients.

8. Sample Size for the Training Set

This device is a reagent for a clinical chemistry assay, not an AI/ML algorithm that requires a "training set" in the conventional sense. The development of such assays involves extensive R&D and optimization, but not typically a labeled "training set" of data for algorithm learning.

9. How the Ground Truth for the Training Set Was Established

As stated above, the concept of a "training set" and associated "ground truth" establishment for algorithm learning does not apply to this type of in vitro diagnostic device. The development and validation process relies on established analytical chemistry principles and performance testing against recognized standards and methods.

Summary

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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.SZone Industrielle61500 SEESFRANCE
3. Contact Person:	Debra K. HutsonDirector, QARA, North America21720 23rd Dr SE, Suite 150Bothell, WA 98021Phone: 425-482-5174Fax: 425-482-5550Email: d.hutson@elitechgroup.com
4. Device Description:	ELITech Clinical Systems AMYLASE SL
Classification	Class IIJFJClinical Chemistry21 CFR 862.1070
Device Description:	ELITech Clinical Systems ELICAL 2
Classification	Class IIJIXClinical Chemistry21 CFR 862.1150
Device Description:	ELITech Clinical Systems ELITROL I and ELITROL II
Classification	Class I, reservedJJYClinical Chemistry
5. Predicate Device:	K063744Roche DiagnosticsAMYL2 (α-Amylase EPS ver.)K033501Roche DiagnosticsCalibrator for Automated Systems (C.f.a.s.)K041227Roche DiagnosticsPrecinorm and Precipath
6. Intended Use
Reagents:	ELITech Clinical Systems AMYLASE SL is intended forthe quantitative in vitro determination of amylase in humanserum and plasma on ELITech Clinical Systems Selectraanalyzers. It is not intended for use in Point of Caresettings. Measurements of amylase are used primarily forthe diagnosis and treatment of pancreatitis (inflammationof 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:

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

8. Substantial Equivalence Information -

Assay

1. Predicate Device Name
- Roche Diagnostics AMYL2 (a-Amylase EPS ver.)
1. K063744
1. Comparison with predicate

Similarities

Parameter	AMYLASE SL	Roche Diagnostics AMYL2(α-Amylase EPS ver.)
Intended Use	Intended for the quantitativein vitro determination ofamylase in human serum andplasma on ELITech ClinicalSystems Selectra analyzers.It is not intended for use inPoint of Care settings.	In vitro test for thequantitative determination ofamylase in human serum andplasma on the cobas c111system.
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(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 calibrationmaterial (not included):ELITech Clinical SystemsELICAL 2	Recommended calibrationmaterial (not included):Roche Calibrator f.a.s.
Interference	Triglycerides: No significantinterference up to 3000mg/dL.Unconjugated bilirubin: Nosignificant interference up to30.0 mg/dL (513 µmol/L).Conjugated bilirubin: Nosignificant interference up to29.5 mg/dL (504 µmol/L).Ascorbic acid: No significantinterference up to 20.0mg/dL.Acetaminophen: Nosignificant interference up to30.0 mg/dL.Acetylsalicylic acid: Nosignificant interference up to200.0 mg/dL.	Hemoglobin: No significantinterference up to an H Indexof 100 (approximate 100mg/dL).Lipemia (Intralipid): Nosignificant influence up to anL index of 1000. Icterus: Nosignificant influence up to IIndex of 15 (approximateconjugated and unconjugatedbilirubin concentration of 15mg/dL (257µmol/L)).
Reference Range	Serum/plasma:1< 31-107 U/L	Serum/plasma: 28-100 U/L

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
1. K041227

1. Comparison with predicate

Similarities and Differences
Item	Candidate Device(ELITech Clinical SystemsELITROL I and ELITROLII)	PredicateRoche DiagnosticsPrecinorm U and Precipath U(K041227)
Intended Use/Indications forUse	ELITech Clinical SystemsELITROL I and ELITROL IIare multi-parametric controlsera for in vitro diagnosticuse in quality control ofquantitative ELITechClinical Systems methods onELITech Clinical SystemsSelectra Analyzers.	Precinorm U is for use in qualitycontrol by monitoring accuracyand precision for the quantitativemethods as specified in thevalue sheets.Precipath U is for use inquality control by monitoringaccuracy and precision forthe quantitative methods asspecified in the value sheets.
Format	Lyophilized human sera withconstituents added asrequired to obtain definedcomponent levels	Same
Levels	Two Levels (Level I andLevel II)	Same
Stability	Lyophilized: Store at 2-8°Cand protected from light untilthe expiry date. AfterReconstitution: 12 hoursbetween 15-25°C, 5 daysbetween 2-8°C, 4 weeksbetween -25 and -15°C(when frozen once)	Same

Calibrator

1. Predicate Device Name:
Roche Diagnostics Calibrator for Automated Systems (C.f.a.s)
1. K033501

Comparison with predicate

Similarities and Differences
Item	Candidate Device(ELITech Clinical SystemsELICAL 2)	PredicateRoche Calibrator forAutomated Systems (C.f.a.s.)K033501
Intended Use/Indications forUse	ELITech Clinical SystemsELICAL 2 is a multi-parametric calibrator for invitro diagnostic use in thecalibration of quantitativeELITech Clinical Systemsmethods on ELITech ClinicalSystems Selectra analyzers.	Calibrator for automated systems(C.f.a.s.) is for use in thecalibrationof quantitative Roche methodson Roche clinical chemistryanalyzersas specified in the value sheets.

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Format	Lyophilized calibrator basedon human serum withconstituents added asrequires to obtain desiredcomponent levels	Same
Level	Single Level	Same
Stability	Lyophilized: store at 2-8°Cand protect from light until theexpiry date.After reconstitution: 8 hoursbetween 15-25°C, 2 daysbetween 2-8°C, 4 weeksbetween -25 and -15°C(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

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 (301) 796-5450. 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 (301) 796-5680 or at its Internet address http://www.fda/gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

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

Page 3 of 3

Regulation Number and Section

§ 862.1070 Amylase test system.

(a)
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).(b)
Classification. Class II.