VITALAB AMYLASE REAGENT

K040534 · Clinical Data, Inc. · JFJ · Mar 11, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040534
• Device Name: VITALAB AMYLASE REAGENT
• Applicant: Clinical Data, Inc.
• Product Code: JFJ · Clinical Chemistry
• Decision Date: Mar 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Vitalab ot-Amylase Reagent Kit is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of a-amylase in serum and plasma. Amylase results may be used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Device Story

Vitalab a-Amylase Reagent is a single-part reagent used with the Vitalab Selectra Analyzer. It measures amylase levels in serum and plasma samples via cleavage of 2-chloro-4-nitrophenyl-a-D-maltotrioside (CNP-a-G3) to produce 2-chloro-4-nitrophenol. The analyzer performs quantitative analysis; results are provided to clinicians to assist in diagnosing and treating pancreatitis. Used in clinical laboratory settings by trained personnel. The device provides quantitative amylase concentration values, aiding clinical decision-making regarding pancreatic inflammation.

Clinical Evidence

Bench testing only. Precision studies (n=60 per sample) showed total CVs of 0.9-1.7%. Linearity was confirmed up to 1,645 U/L (default) and 3,311 U/L (rerun). Method comparison (n=120) against the predicate device yielded a slope of 1.086 and intercept of -6.1 U/L. Interference testing evaluated bilirubin, hemoglobin, and triglycerides, with specific suppression thresholds identified. No clinical patient outcome studies were performed.

Technological Characteristics

Single-part liquid reagent; catalytic enzymatic assay using CNP-a-G3 substrate. Designed for use on Vitalab Selectra Analyzer. Quantitative photometric measurement. No specific materials of construction or connectivity standards provided.

Indications for Use

Indicated for the diagnosis and treatment of pancreatitis in adult patients.

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).

Predicate Devices

• Roche alpha-Amylase EPS Ver.2 Reagent (k972250)

Submission Summary (Full Text)

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K040534

:

Brea, CA 92821 T [phone] F [phone]

> Summary of 510(k) Safety and Effectiveness Information Vitalab a-Amylase Reagent

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

#### Submitted by:

| | Clinical Data, Inc.<br>1075 West Lambert Road, Building D<br>Brea, California 92861 | |
|-----------------|-------------------------------------------------------------------------------------|----------------------------|
| Contact Person: | Wynn Stocking | Regulatory Affairs Manager |

January 21, 2003 Date Submitted:

#### Device Names:

| Proprietary name: | Vitalab Amylase Reagent |
|----------------------|----------------------------|
| Common name: | Amylase reagent |
| Classification Name: | Catalytic methods, amylase |

### Device Description:

The Vitalab a-Amylase Reagent is a single-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines amylase through the cleavage of 2-chloro-4-nitrophenyl-a-D-maltotrioside (CNP-a-G3) to produce 2-chloro-4-nitrophenol.

#### Intended Use:

The Vitalab ot-Amylase Reagent Kit is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of a-amylase in serum and plasma. Amylase results may be used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

#### Predicate Device:

Roche a-Amylase EPS ver.2 Reagent, product no. 03183742, which is currently marketed by Roche Diagnostics Corp. of Indianapolis, IN

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## Summary of Performance Data:

| Usable Range: The linear range of the Vitalab α-Amylase Reagent is 5 to 1,600 U/L using the default sample volume<br>and 1,200 to 3,200 U/L using the reduced sample volume in rerun mode. The recoveries of linearity<br>related solutions that span the linear range are compared to dilution factors using least squares<br>regression, which is forced through the origin. | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|-------|-----|------|-----|------|
| Default sample volume<br>(Vitalab Recoveries) = 0 U/L + 131 x (Dilution Factor), r = 0.9999, syx = 7.2 U/L, n = 28 | | | | | | | |
| Rerun sample volume<br>(Vitalab Recoveries) = 0 U/L + 133 x (Dilution Factor), r = 0.9999, syx = 17 U/L, n = 60 | | | | | | | |
| Detection Limit: The detection limit is shown through the repetitive assay of normal saline. The observed mean and<br>standard deviation of a 30 replicate run are 0.3 and 1.8 U/L respectively. The detection limit,<br>calculated as the mean plus two standard deviations of the recovery values, is 0.4 U/L. | | | | | | | |
| Precision: | Precision is demonstrated by the replicate assay of control serum. Precision statistics, calculated<br>analogous to the method described in NCCLS Guideline EP3-T, are shown below. | | | | | | |
| | Sample | n | mean | 1SD | %CV | 1SD | %CV |
| | Default | | | | | | |
| | Serum 1 | 60 | 98 | 1.0 | 1.0% | 1.5 | 1.5% |
| | Serum 2 | 60 | 565 | 3.6 | 0.6% | 5.0 | 0.9% |
| | Serum 3 | 60 | 1,034 | 7.0 | 0.7% | 9.7 | 0.9% |
| | Rerun | | | | | | |
| | Serum 1 | 60 | 1,961 | 17 | 0.9% | 25 | 1.3% |
| | Serum 2 | 60 | 2,517 | 26 | 1.0% | 41 | 1.6% |
| | Serum 3 | 60 | 3,002 | 40 | 1.3% | 50 | 1.7% |
| Correlation: | Mixed serum and plasma specimens, collected from adult patients, were assayed for α-amylase using<br>the Vitalab Selectra E Analyzer and another commercially available method. Results were compared<br>by Deming regression and the following statistics were obtained. | | | | | | |
| | Selectra = -6 U/L + 1.086 x Competitive Reagent<br>sy.x = 4.0 U/L     n = 120     range = 26 - 1049 U/L | | | | | | |
| Stability: | The 14 day onboard reagent stability claim is documented through the assay of serum controls over the<br>claimed period. The statistical estimates of total imprecision are less than 2 U/L or 1.2% for all<br>controls | | | | | | |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 1 2004

Clinical Data, Inc. c/o: Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, MI 49548

Re: k040534 Trade/Device Name: Vitalab a-Amylase Reagent Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase test system Regulatory Class: Class II Product Code: JFJ Dated: March 2, 2004 Received: March 2, 2004

Dcar Mr. Devine:

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 docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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/dsma/dsmamain.html.

Sincerely vours.

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

# K040534

Device Name:

Vitalab a-Amylase Reagent

Indications for Use:

The Vitalab c .- Amylase Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of a-amylase in serum and plasma. Amylase results may be used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

**Office of In Vitro Diagnostic**
**Device Evaluation and Safety**

510(k) K040534

Prescription Use
(Per 21 CFR 801.109) √

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Over-The-Counter Use

(Optional Format 1-2-96)