CARESIDE CALCIUM, ORIGINAL

K983789 · Careside, Inc. · CJY · Dec 17, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983789
• Device Name: CARESIDE CALCIUM, ORIGINAL
• Applicant: Careside, Inc.
• Product Code: CJY · Clinical Chemistry
• Decision Date: Dec 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Indications for Use

The CARESIDE™ Calcium cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer™ to quantitatively measure calcium concentration in heparinized whole blood, heparin plasma, or serum.

Device Story

CARESIDE™ Calcium is a single-use disposable cartridge used with the CARESIDE Analyzer™ for quantitative calcium measurement in heparinized whole blood, heparin plasma, or serum. The cartridge contains a multi-layer reagent film. The user deposits the specimen into the cartridge, closes the lid, and inserts it into the analyzer. The analyzer scans the barcode, heats the cartridge to 37°C, and spins it to distribute the sample. Plasma/serum is dispensed onto the reagent film; a dye complex (chlorophosphonazo III) forms in the presence of calcium. A photodiode measures light reflectance at 615 nm. The analyzer uses reflectance measurements and a lot-specific standard curve to calculate calcium concentration. Results are used by laboratory professionals to assess parathyroid function, vitamin D status, calcium metabolism, and diagnose conditions like Addison's disease or malignancies. The device provides rapid, automated analysis, reducing the need for manual pipetting and reagent pre-warming compared to traditional methods.

Clinical Evidence

Bench testing and method comparison study. Accuracy: mean recovery 98%. Precision: total CV 7.8% at 6.5 mg/dL. Method comparison against a 2-cresolphthalein complexone colorimetric reference method yielded r=0.95. Linearity was within acceptable limits. Interference testing showed no significant impact from ascorbic acid (10 mg/dL), bilirubin (10 mg/dL), hemoglobin (250 mg/dL), magnesium (2.5 mmol/L), or triglycerides (600 mg/dL).

Technological Characteristics

Dry film reagent cartridge containing chlorophosphonazo (III). Sensing principle: reflectance photometry at 615 nm. Energy source: CARESIDE Analyzer (37°C heating, centrifugal sample distribution). Dimensions: single-use cartridge. Connectivity: barcode-based lot-specific calibration. Software: automated processing of reflectance data against standard curves.

Indications for Use

Indicated for in vitro diagnostic use to quantitatively measure total calcium from heparinized whole blood, heparin plasma, or serum specimens to aid in the diagnosis and treatment of patients with parathyroid disease, bone diseases, chronic renal disease, and tetany. Intended for professional laboratory use; not for point-of-care or physician office laboratory use.

Regulatory Classification

Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Predicate Devices

• Vitros Ca DT Slides for Johnson and Johnson's Vitros DTSC II (K912844/A)

Submission Summary (Full Text)

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CARESIDE, Inc.

Page 13

CARESIDE™ Calcium (K983789) Premarket Notification Addendum December 11, 1998

K983789

# Attachment 3: Revised 510(k) Summ

## 510(K) SUMMARY: CARESIDE™ CALCIUM SAFETY AND EFFECTIVENESS 1

#### I. Applicant Information

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

#### Device Information II.

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

D. Special controls and performance standards

#### 111. Substantial Equivalence Claim

#### General equivalency claim A.

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

Calcium in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market, including calcium products that utilize and dye reactions.

#### B. Specific equivalency claim

This CARESIDE™ Calcium test is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of calcium on the Vitros DTSC II.

Name of Predicate Device:

Predicate Device 510K number: Product Code:

Johnson and Johnson's (formerly Eastman Kodak, Inc.) Vitros Ca DT Slides for Johnson and Johnson's Vitros DTSC II (formerly Eastman Kodak's DTSC II).

K912844/A 75CJY

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 11, 1998

- CARESIDE™ Calcium
Calcium test system Clinical chemistry panel Calcium test system Regulation Number: 21 CFR 862.1145 Regulatory Class II Classification Number: 75CJY None applicable

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CARESIDE, Inc. Page 14

#### IV. Device Description

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

#### Explanation of Device Function A.

Each CARESTDE™ Calcium cartidge consists of a calcium-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge sample deposition 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°C, and spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers. 8.5uL of sample remains in the metering passage. Any excess sample flows into an overflow well.

The plasma (or serum, as applicable) is automatically dispensed onto the multi-layer reagent film. The spreading layer distributes the sample evenly on the film, and the sample moves through a reagent layer and a detection layer where a dye complex forms in the presence of calcium. The color intensity of the resulting blue dye, as measured by the amount of reflected light at 615 nanometers directly relates to the calcium concentration of the specimen.

Test Reaction Sequence: Ca + Bound-Ca -> Ca +2 Ca-2 + chlorophosphonazo (III) -> Ca-chlorophosphonazo (III)

As the cartidges spin, a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) at a fixed time. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate calcium concentration.

#### B. Test Summary

Calcium is an element found in fairly fixed proportions in the mineral phase of the human hard tissues (bone, dentine, and enamel) as well as in dynamic exchange with the intracellular and extracellular tissue fluids. Over 95% of the body calcium store is in the skeleton and tecth. Of the blood calcium, 45-50% is ionized, 40-45% is protein-bound and about 10% is chelated with ligands like citrate, lactate, phosphate and bicarbonates".

Intracellularly, calcium (Ca 1) is a prime inorganic messenger for cell function regulation, Extracellular Cat2 at the cell surface controls secretions from several endocrine glands including the parathyroid and pancreas. Calcium also plays a key role in blood coagulation.

The three main regulators of calcium homeostasis are parathyroid hormone, vitamin D, and calcitonin. Disorders involving these regulators directly impact calcium levels. Calcium level determination in human body fluids is used to measure parathyroid function, to assess vitamin D status; to evaluate calcium metabolism; to diagnose Addison's disease and to investigate malignancies . Increased calcium levels are seen in cases of hyperparathyroidism and malignancy. Reduced levels are commonly seen in cases of hypoalbuminemia

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CARESIDE, Inc. Page 15

CARESIDE™ Calcium (K983789) Premarket Notification Addendum December 11, 1998

#### Intended Use V.

- A. Intended Use
The CARESIDE™ Calcium cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer™ to quantitatively measure calcium concentration in heparinized whole blood, heparin plasma, or serum.

#### B. Indications for Use

For in vitto diagnostic use with the CARESIDE Analyzer™ to quantitatively mensure total calcium from heparinized whole blood, heparin plasma or serum specimens to aid in diagnosis and treatment of patients with parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany. It is intended for professional laboratory use: not for point of care or physician office laboratory use.

#### VI. Technological Characteristics

- Similarities A.

| | CARESIDE™ Calcium | Vitros CA DT Slides |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use | Primarily to aid in the diagnosis and treatment of patients with parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany (intermittent muscular contractions or spasms). | Same |
| Indications | For in vitro diagnostic use.<br>For professional laboratory:<br>not for point of care or<br>physician office laboratory use. | For in vitro diagnostic use |
| Measurement | Quantitative | Same |
| Method Principle | Dry film based already on the U.S. market, including calcium products that utilize azo dye reactions. | Same |
| Specimen | Not required | Same |
| Materials | Chlorophosphonazo (III) | Arsenazo (III) dye |
| Detector | Reflectance (615) | Reflectance (680 nm) |
| Test time | Approx. 4-minute warm-up<br>(on-board) plus 4 minute test<br>time. | 15 minutes slide warm-up<br>(off-line) plus 5 minutes test<br>time. |
| Reference Method | 2-cresolphthalein complexone<br>colorimetric | Atomic Absorption<br>Spectrophotometry |
| Sample Type | Heparinized whole blood,<br>heparin plasma or serum | Same |
| Specimen volume | 8.5 µl test volume<br>(85 ± 15 µl applied volume) | 10 µl |
| Calibration | Calibration information bar-<br>coded on each cartridge.<br>Calibration information may<br>change with each lot. | Run Vitros DTSC II<br>calibrators whenever a new<br>slide lot is used or when<br>necessary. |
| Quality Control | 2 levels | Same |
| Reporting Units | mg/dL or mmol/L | Same |
| Reaction Temp. | 37 °C | Same |

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CARESIDE, Inc. Page 16

CARESIDE™ Calcium (K983789) Premarket Notification Addendum December 11, 1998

- B. Differences

| | CARESIDE™ Calcium | Vitros CA DT Slides |
|------------------------|-------------------|---------------------|
| Specimen pre-treatment | Required | Required |
| Reportable range | 4.2 to 14 mg/dL | 3 to 14 mg/dL |
| Accurate<br>pipetting | Not required | Required |
| Reagent pre-warming | Not required | Required |

Comparative Performance Characteristics C.

| | CARESIDE™ Calcium | Vitros Ca DT Slides |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Detection limit | 4.2 mg/dL | 3 mg/dL |
| Reportable range | 4.2 to 14 mg/dL | 3 to 14 mg/dL |
| Accuracy | Mean recovery 98% | Not provided |
| Precision | Total CV at 6.5mg/dL, 7.8% | Total CV at 11.9 mg/dL = 1.6% |
| Method comparison | CARESIDE™ = 0.90 (Reference Method) + 1.09 mg/dL, r = 0.95 | |
| Linearity | Linearity yielded slope and correlation coefficient within acceptable limits. | Not provided |
| Interference | No significant interference observed at tested concentration of interferent:<br>Ascorbic Acid, 10 mg/dL<br>Bilirubin, 10 mg/dL<br>Hemoglobin, 250 mg/dL<br>Magnesium 2.5 mmol/L<br>Triglycerides 600 mg/dL | Not provided |

Conclusion D.

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

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 7 1998 Kenneth B. Asarch, Pharm. D., Ph.D. Vice President Quality Systems and Regulatory Affairs CARESIDE, Inc. 6100 Bristol Parkway Culver City, California 90230

Re: K983789 CARESIDE™ Calcium for use on the CARESIDE Analyzer™ Trade Name: Regulatory Class: II Product Code: CJY Dated: October 26, 1998 Received: October 27, 1998

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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory 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

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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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## VI. INDICATIONS FOR USE

510(k) Number:

K983789

Device Name:

CARESIDE™ Calcium

For in vitro diagnostic use with the CARESIDE Analyzer™ to measure total Indications for use: calcium from heparinized whole blood, heparin plasma or serum specimens to aid in the diagnosis and Catchin from nepartnized whole brood, nepa a variety of bone diseases, chronic renal disease, and tetany. u catinent of pations with paraly of ences, at for point of care or physician office laboratory use.

| (Division Sign-Off) |
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Divi al Labora vices

| 510(k) Number | K983789 |
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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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