CARESIDE AMYLASE

K990025 · Careside, Inc. · JFJ · Feb 8, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990025
• Device Name: CARESIDE AMYLASE
• Applicant: Careside, Inc.
• Product Code: JFJ · Clinical Chemistry
• Decision Date: Feb 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Intended Use

The CARESIDE™ Amylase cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer™ to quantitatively measure amylase activity in whole blood, serum or plasma.

Device Story

CARESIDE™ Amylase is a single-use disposable cartridge used with the CARESIDE Analyzer™ to measure amylase activity in whole blood, serum, or plasma. The user loads the specimen into the cartridge, which contains a multi-layer reagent film. The analyzer scans the barcode, heats the cartridge to 37°C, and spins it to distribute the sample. Amylase in the sample reacts with a synthetic substrate (PNP-Gm) to produce a yellow dye. The analyzer uses reflectance photometry at 425 nm to measure color intensity, which correlates to amylase activity. The system calculates results using lot-specific standard curves. Used in professional laboratory settings to aid in diagnosing pancreatic, salivary gland, and kidney diseases. Benefits include automated processing, eliminating manual specimen dilution, pipetting, and reagent pre-warming.

Clinical Evidence

Bench testing only. Performance evaluated via method comparison against Trace Scientific Amylase DST (r=0.97) and Vitros AMYL DT (r=0.95). Precision reported as total CV of 13% at 75 U/L. Detection limit is 15 U/L with a reportable range of 15-600 U/L. Interference testing showed no significant impact from ascorbic acid (20 mg/dL), hemoglobin (100 mg/dL), or triglycerides (1500 mg/dL).

Technological Characteristics

Dry film reagent cartridge; sensing via reflectance photometry at 425 nm; reaction temperature 37°C. Reagents: p-nitrophenyl-α-D-maltopentaoside and α-glucosidase. Connectivity: Barcode-based lot-specific calibration. System performs automated sample metering and distribution via centrifugal force. No manual dilution or pre-warming required.

Indications for Use

Indicated for use in the diagnosis and treatment of patients with disease of the pancreas, salivary gland, and kidney. For professional laboratory use; not for point-of-care or physician office use.

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

• Vitros AMYL Slides for Johnson and Johnson's Vitros DT 60 II system (K912844/A)

Submission Summary (Full Text)

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K990035

CARESIDE, Inc. Page 10

## 510(K) SUMMARY: CARESIDE™ AMYLASE SAFETY V. AND EFFECTIVENESS

#### I. Applicant Information

- Applicant Name A.
- Applicant/Manufacturer Address B.
- ட் Telephone Number
- Contact Person D.
- FAX Number E.
- F. e-Mail Address
- G. Date 510(k) Summary prepared

#### II. Device Information

- Device Name (Trade) A.
- B. Device Name (Classification)
- C. Device Classification

## CARESIDE, Inc.

6100 Bristol Parkway Culver City, CA 90230 310-338-6767 Kenneth B. Asarch, Pharm.D., Ph.D. 310-338-6789 [e-mail] December 30, 1998

### CARESIDE™ Amylase

Amylase test system Clinical chemistry panel Amylase test system Regulation Number: 21 CFR 862.1070 Regulatory Class 2 Classification Number: 75JFJ None applicable

D. Special controls and performance standards

#### III. Substantial Equivalence Claim

- A. General equivalency claim
The ability to monitor analyte-specific biochemical reactions in dry film and other formats is widely recognized and has gained widespread acceptance for use in chemistry assays.

Amylase in vitro diagnostic products, in both dry film and other formats, are already on Amylase products include those that use amyloclastic methods the U.S. market. (measure the disappearance of substrate and include the iodine-starch method), saccharogenic methods (measure the production of sugars such as maltose and glucose), and chromogenic methods (measure a colored product).

#### B. Specific equivalency claim

This CARESIDE™ Amylase test is substantially equivalent in intended use and clinical performance to the currently marketed Vitros slides for the quantitative measurement of amylase on the Vitros DT 60 II system with the DTSC II module. Both are based on the principle of dry film and are read by reflectance photometry; however, the Vitros method is based upon the conversion of dyed starch to dyed saccharides while the CARESIDE method is based upon the conversion of a synthetic substrate to a colored product.

Name of Predicate Device: Johnson and Johnson's (formerly Eastman Kodak, Inc.) Vitros AMYL Slides for Johnson and Johnson's Vitros DT 60 II system with the DTSC II module (formerly Eastman Kodak's DT 60 II). Predicate Device 510K number: K912844/A Product Code: 75CIW

FEB

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#### IV. Device Description

CARESIDE™ Amylase cartridges are used with the CARESIDE Analyzer™ to measure amylase activity in whole blood, serum or plasma specimens. The CARESIDE™ Amylase cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of serum or plasma to a dry film to initiate the measurement of amylase activity. The film cartridge (patent pending) contains all reagents necessary to measure amylase activity.

#### Explanation of Device Function A.

Each CARESIDE™ Amylase cartridge consists of an amylase-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge Sample Well, closes the lid and inserts the cartridge into the CARESIDE Analyzer™.

Once loaded, the CARESIDE Analyzer™ scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the Sample Well into the cartridge channels and chambers. 8.5 microliters of sample remains in the metering passage. Any excess sample flows into an overflow well.

The 8.5 microliters of sample is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer distributes the specimen uniformly. Amylase p-nitrophenyl-α-D-maltopentaoside to p-nitrophenyl-oligosaccharides converts (PNP-Gm) and free oligosaccharides (Gn). The sample mixture diffuses into the underlying detection layer where PNP-Gm is converted by a-glucosidase to generate Gm and p-nitrophenol which converts to a vellow dye. The color intensity of the resulting yellow dye, as measured by the amount of reflected light at 425 nanometers, directly relates to the amylase activity of the specimen.

Test Reaction Sequence:

amylase > PNP-Gm + Gn (m+n=5) PNP-Gs a-glucosidase > PNP + Gm PNP-Gm -

As the cartridges spin. a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) over a fixed time period. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate amylase activity.

#### B. Test Summary

Amylase is an enzyme produced by the pancreas and parotid glands that occurs in blood. Amylase catalyzes the hydrolysis of starch and related polysaccharide to yield maltose and other oligosaccharides. Amylase activity in the blood is elevated in inflammation and hemorrhage of the pancreas and is decreased in pancreatic insufficiency. Amylase measurement is useful in the differential diagnosis of the digestive system. Various other causes of hyperamylasemia include salivary lesions, biliary tract disorders, trauma, neoplastic diseases, ruptured ectopic pregnancy, pulmonary disease, and alcoholic intoxication. Certain drugs can also increase amylase activity in the blood in vivo.

#### V. Intended Use

#### A. Intended Use

The CARESIDE™ Amylase cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer™ to quantitatively measure amylase activity in whole blood, serum or plasma.

- B. Indications for Use
This product is indicated for use in the diagnosis and treatment of patients with disease of the pancreas, salivary gland, and kidney.

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#### VI. Technological Characteristics

- A. Similarities

| | CARESIDE™ Amylase | Vitros AMYL DT Slides |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Intended Use | Primarily to aid in the diagnosis and treatment of patients with disease of the pancreas, salivary gland, and kidney.<br>For <i>in vitro</i> diagnostic use. | Primarily to aid in the diagnosis of diseases of the pancreas<br>For <i>in vitro</i> diagnostic use |
| Indications | For professional laboratory:<br>not for point of care or physician office laboratory use. | |
| Measurement | Quantitative | Same |
| Method Principle | Dry film, p-nitrophenyl-α-D-maltopentaoside substrate reaction coupled with α-glucosidase | Dry film conversion by amylase of high molecular weight dyed starch into low molecular weight dyed saccharides |
| Specimen dilution | Not required | Same |
| Materials | p-nitrophenyl-α-<br>D-maltopentaoside,<br>α-glucosidase | Dyed amylopectin |
| Detector | Reflectance (425 nm) | Reflectance (555 nm) |
| Test time | Approx. 4 minute warm-up (on-board) plus approximately 6 minute test time. | 15 minutes slide warm-up (off-line) plus 5 minutes test time. |
| Reference Method | Rate determination using ethylidene-pNP-G7 substrate, spectrophotometric detection, 37 °C | PNP Maltopentaoside Method, 37 °C |
| Sample Type | Anti-coagulated whole blood, serum, or heparinized plasma. | Serum or heparinized plasma |
| Specimen volume | 8.5 µl test volume<br>(85 ± 15 µl applied volume) | 10 µl |
| Calibration | Calibration information bar-coded on each cartridge.<br>Calibration information may change with each lot. | Run Vitros DT II calibrators whenever a new slide lot is used or when necessary. |
| Quality Control | 2 levels | Same |
| Reporting Units | U/L | Same |
| Reaction Temp. | 37 °C | Same |

#### B. Differences

| | CARESIDE™ Amylase | Vitros AMYL DT Slides |
|-------------------------|-------------------|-----------------------|
| Specimen<br>Processing | Not required | Required |
| Accurate<br>pipetting | Not required | Required |
| Reagent pre-<br>warming | Not required | Required |

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#### Comparative Performance Characteristics C.

| | CARESIDE™ Amylase | Vitros AMYL DT Slides |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Detection limit | 15 U/L | 5 U/L |
| Reportable range | 15 to 600 U/L | 5 to 900 U/L |
| Accuracy | Mean recovery 95% | Not provided |
| Precision | Total CV, 75 U/L, 13% | Total CV, 51 U/L, 13% |
| Method<br>comparison | CARESIDE™ = 0.94 (Trace Sci. Amylase DST) + 11.5 U/L, r = 0.97<br>CARESIDE™ = 0.76 (Vitros AMYL DT) + 14.6 U/L, r = 0.95 | |
| Linearity | Linearity yielded slope and<br>correlation coefficient within<br>acceptable limits. | Not provided |
| Interference | No significant interference observed at tested concentration of interferent:<br>Ascorbic Acid,........20 mg/dL<br>Hemoglobin,......... 100 mg/dL<br>Triglycerides ..... 1500 mg/dL | No reported interference |

#### D. Conclusion

The nonclinical and clinical data provided demonstrate that the CARESIDE™ Amylase product is as safe, effective, and performs as well as or better than the legally marketed predicate device

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FEB 8 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kenneth B. Asarch, Pharm. D., Ph.D. Vice President, Quality Systems/ Regulatory Affairs Careside Inc. 6100 Bristol Parkway Culver City, California 90230

Re: K990025 Trade Name: CARESIDE™ Amylase Regulatory Class: II Product Code: JFJ Dated: December 30, 1998 Received: January 5, 1999

Dear Dr. Asarch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CARESIDE, Inc. Page 15

# VII. INDICATIONS FOR USE

510(k) Number:

K 990025

Device Name:

CARESIDE™ Amylase

Indications for use:

For in vitro diagnostic use with the CARESIDE Analyzer™ to measure amylase from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with disease of the pancreas, salivary gland, and kidney.

Alan Cooper

orv Devices

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)