CARESIDE ALBUMIN

K980041 · Exigent Diagnostics, Inc. · CIX · Feb 4, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980041
• Device Name: CARESIDE ALBUMIN
• Applicant: Exigent Diagnostics, Inc.
• Product Code: CIX · Clinical Chemistry
• Decision Date: Feb 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended Use

The CareSide™ Albumin product is intended for in virro diagnostic use when used with The Exigent Diagnosucs CareSide™ Analyzer to measure albumin concentration in whole blood, plasma or serum specimens. When used in conjunction with the Exigent Diagnostics CareSide™ Total Protein cartridge on the CareSide™ Analyzer, the device may be used to calculate globulin and albumin concentrations and the albumin/globulin ratio (A/G ratio). Albumin test aids in the diagnosis and treatment of numerous diseases involving mainly the liver or kidneys.

Device Story

CareSide™ Albumin is a single-use disposable cartridge used with the CareSide™ Analyzer. Input: whole blood, plasma, or serum specimen. Operation: user deposits sample into cartridge; analyzer heats to 37°C and spins to separate blood cells from plasma/serum; 10 μL of sample is automatically metered onto a multi-layer reagent film. Principle: bromocresol green complexation forms a blue dye proportional to albumin concentration. Analyzer uses LEDs and photodiodes to measure reflectance at 615 nm. Output: quantitative albumin concentration (and A/G ratio when used with Total Protein cartridge). Used in clinical settings by professionals. Output assists clinicians in diagnosing/treating liver or kidney diseases by identifying hypoalbuminemia or hyperalbuminemia.

Clinical Evidence

Bench testing only. Performance evaluated against Vitros Albumin DT slides. Method comparison yielded r=0.96 (y=0.95x + 0.14). Precision (Total CV) reported at 5.3% for 4.3 g/dL. Mean recovery 107%. Interference testing showed no significant impact from ascorbic acid (20 mg/dL), bilirubin (20 mg/dL), hemoglobin (250 mg/dL), or triglycerides (3000 mg/dL). Reportable range 1.0 to 6.0 g/dL.

Technological Characteristics

Single-use plastic cartridge with multi-layer reagent film. Sensing principle: reflectance photometry (615 nm). Energy source: CareSide™ Analyzer (electrical). Reaction temperature: 37°C. Connectivity: barcode-based calibration. Software: rule-based calculation using lot-specific standard curves.

Indications for Use

Indicated for professional in vitro diagnostic use to measure albumin in whole blood, plasma, or serum to aid in the diagnosis and treatment of diseases involving the liver or kidneys.

Regulatory Classification

Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Predicate Devices

• Johnson and Johnson's Vitros Albumin Slides (K912844/A)

Submission Summary (Full Text)

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Exigent Diagnostics, Inc. Page 12

# CarcSide™ Albumin Premarket Notification revised on January 27, 1998

510(K) SUMMARY: V.

## CARESIDE™ ALBUMIN EFFECTIVENESS

#### Applicant Information I.

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

#### Device Information ਸ਼ਾ

- A. Device Name (Trade)
- Device Name (Classification) B.
- Device Classification C.
- Device Tier D.
- Special controls and uj performance standards

#### Substantial Equivalence Claim III.

- General equivalency claim A.
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.

Albumin in virro diagnostic products, in both dry film and other formats, are already on the U.S. market including Albumin products which utilize bromocresol green complexation.

- B. Spocific equivalency claim
This CareSide™ Albumin product is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantiative measurement of albumin on the Vitros DT 60 II.

| Name of Predicate Device: | Johnson and Johnson's Vitros Albumin Slides<br>(formerly Eastman Kodak, Inc.). |
|-------------------------------|--------------------------------------------------------------------------------|
| Predicate Device 510K number: | K912844/A |
| Product Code: | 75CIX |

## Exigent Diagnostics, Inc. 6100 Bristol Parkway

Culver City, CA 90230 310-338-6767 Kenneth B. Asarch, Pharm.D., Ph.D. 310-338-6789 asarchk @ worldnet.aut.net January 27, 1998

### CarcSide™ Albumin

Albumin test system Clinical chemistry panel Albumin test system Regulation Number: 21 CFR 862.1035 Regulatory Class II licr l None applicable

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Exigent Diagnostics, Inc. Page 12a

CareSide™ Albumin Premarket Notification revised on January 27, 1998

#### IV. Device Description

CareSide™ Albumin cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure albumin concentration in whole blood, plasma or serum specimens. The Careshie Albumin carridge, a single use disposable in virro diagnostic test carridge, aids in speciment separation and delivers a measured volume of plasma or sorum to a dry film to initiate the moasuroment of albumin concentration. The film cartidge (patent pending) contains all reagons and necessary to measure albumin concentration. When used in conjunction with the CareSide™ Total Protein carridge on the CareSidorM Analyzer calculates globulin (as the I vial Prolent Caral go on the and albumin concentrations) and the albumin/globulin ratio (A/G ratio).

#### Explanation of Device Function A.

Each Exigent Diagnostics CareSide™ Albumin cartridge consists of an albumin-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the whole blood, serum, or plasma specimen into the cartridge sample deposition wcll, closes the lid and insuris the cartridge into the Exigent Diagnostics CareSide™ Analyzer.

Once loaded, the CareSide™ analyzer scans the carridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample deposition well into the carridge channels and chambers. As the carridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Ten microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well.

The ten microliters of plasma (or serum, as applicable) is automatically dispensed onlo the multi-layer reagent film. The spreading layer distributes the sample evenly on the film, the sample moves through a spreading and substrate layer where a blue dye forms in the presence of albumin, and the blue albumin-BCG complex diffuses through the buffer layer.

### Test Reaction Sequence:

Albumin + Bromocresol groon -> Albumin-BCG (Blue)

As the cartidges spin, photodiodes measure reflectance of light emitted by wavelengthspecific light emitting diodes (LEDs) at a fixed time. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate albumin concentration.

#### B. Test Summary

Albumin is the single most abundant protein in normal plasma and usually makes up to two thirds of total plasma protein. Medium to heavy albumin concentration changes in plasma have significant effects on the relative amounts of the bound and free concentration of ligands it carries. As a result, albumin levels can influence the receptor interaction and metabolism of cadogenous and exogenous ligands, such as drugs and hormones.

Hyperalbuminemia, an abnormally high plasma alhumin level, is found only with dehydration or, artifactually, in a sample taken with prolonged venostasis, and is usually of little clinical importance. Hypoalbuminemia, a low plasma albumin level, may be caused by dilution of an excess protein-free fluid, redistribution of albumin into the interstitial fluid duc to a decreased synthesis rate, an increased catabolism rate, or by loss from the body.

The most severe hypoalbuminemia is caused by protein loss by way of urine or feces; when plasma albumin levels are less than 2.0 g/dl, edoma is usually present. Normally about 4 percent of the body albumin is replaced each day by hepatic synthesis. Synthesis depends on an adequate dietary supply of amino acids to replace the nitrogen lost, mainly as urinary urea, after protein catabolism.

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**Page 176**

CareSide™ Albumin Premarket Notification revised on January 27, 1998

#### Intended Usc V.

#### Intended Use A.

The CareSide™ Albumin product is intended for in virro diagnostic use when used with The Exigent Diagnosucs CareSide™ Analyzer to measure albumin concentration in whole When used in conjunction with the blood, plasma or serum specimens. Exigent Diagnostics CareSide™ Total Protein cartridge on the CareSide™ Analyzer, the Exigent Diagnostics CareSide™ Tour Freen bulling on ventration and albumings in the albumin device may be used to calediato ground of Albumin test alds in the diagnosis and treatment of numerous diseases involving mainly the liver or kidneys.

#### Indications for Use B.

This product is indicated for use with patients with numerous diseases involving mainly the liver or kidneys.

#### Technological Characteristics VL

#### Similarities A.

| | CareSide™ Albumin | Vitros ALB DT Slides |
|-------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Intended Use | Primarily to aid in the diagnosis and treatment of numerous diseases mainly involving the liver or kidneys. | Same |
| Indications | For <i>in vitro</i> diagnostic use.<br>For professional use only. | For <i>in vitro</i> diagnostic use. |
| Measurement | Quantitative | Same |
| Reportable range | 1.0 to 6.0 g/dL | 1.0 to 6.0 g/dL |
| Method Principle | Dry film based complexation with bromocresol green | Same |
| Specimen dilution | Not required | Same |
| Detector | Reflectance (615 nm) | Reflectance (630 nm) |
| Test time | Approximately 4 minute warm-up (on-board) plus 6 minute test time. | 15 minutes slide warm-up (off-line) plus 3 minutes test time. |
| Reference Method | Bromocresol green (wet) | Bromocresol green (dry film) |
| Sample Type | Serum, plasma, whole blood (wb) [wh applied sample, plasma test sample] | serum, plasma |
| Specimen volume | 10 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. | |
| Quality Control | 2 levels | Same |
| Reporting Units | g/dL or μmol/L | g/dL or g/L |
| Reaction<br>temperature | 37 °C | Same |

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Exigent Diagnostics, Inc. Page 12c

CareSide™ Albumin Premarket Notification revised on January 27, 1998

- Differences B.

| | CareSideTM Albumin | Vitros ALB DT Slides |
|--------------------------|--------------------|--------------------------------------------------------------------------|
| Direct blood<br>specimen | Yes, whole blood | No, requires separation of<br>whole blood prior to sample<br>application |
| Accurate<br>pipetting | Not required | Required |
| Reagent pre-<br>warming | Not required | Required |

### Comparative Performance Characteristics C.

| | CareSide™ Albumin | Vitros Albumin DT Slides |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Detection limit | 1 g/dL | 1 g/dL |
| Reportable range | 1.0 to 6.0 g/dL | 1.0 to 6.0 g/dL |
| Accuracy | Mean recovery 107% | Not provided |
| Precision | Total CV, 4.3 g/dL 5.3% | Total CV, 4.2 g/dL 2.1% |
| Method<br>comparison | CareSide™ = 0.95 (Vitros Albumin DT) + 0.14, r=0.96 | |
| Linearity | Mean deviation approx 5%.<br>r>0.99 | Not provided |
| Interference | No significant interference<br>observed at tested<br>concentration of interferent:<br>Ascorbic Acid, 20 mg/dL<br>Bilirubin. 20 mg/dL<br>Hemoglobin, 250 mg/dL<br>Triglycerides 3000 mg/dL | Not provided |
| Specimen Types<br>& Anticoagulants | No clinically significant<br>difference between<br>heparinized whole blood,<br>serum, heparin plasma, and<br>EDTA plasma. | No clinically significant<br>difference between serum and<br>heparin plasma. Whole<br>blood is unsuitable. |
| Expected Values | 3.6 to 4.5 g/dl.<br>(combined male and female)<br>Central 95% interval | 3.5 to 5.0 g/dL<br>referenced from literature |

#### D. Conclusion

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

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Image /page/4/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 stripes representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

#### 1 1298 FEB

Kenneth B. Asarch, Ph.D. . VP Quality Systems and Regulatory Affairs Exigent Diagnostics Inc. 6100 Bristol Parkway 90230 Culver City, California

K980041 Re : CareSide™ Albumin Regulatory Class: II CIX Product Code: Dated: December 30, 1997 January 6, 1998 Received:

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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ 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 Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 requlations.

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Paqe 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/dsmamain.html".

Sincerely yours,
Steven Sitman

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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Exigent Diagnostics, Inc. Page 14

## VII. Indications for Use

510(k) Number:

kg8064 To be assigned

CareSide™ Albumin Device Name:

Indications for use:

For in vitro diagnostic use with Exigent Diagnostics CareSide Analyzer to measure albumin from whole blood, plasma or serum specimens by professionals to aid in the diagnosis and treatment of a variety of numerous diseases involving mainly the liver or kidneys.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K480041

[prescriptum une]

Qum 1.29-98