CALCIUM, AZO DYE REAGENT

K040972 · Genchem, Inc. · CJY · Dec 27, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040972
• Device Name: CALCIUM, AZO DYE REAGENT
• Applicant: Genchem, Inc.
• Product Code: CJY · Clinical Chemistry
• Decision Date: Dec 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

GenChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diseases associated with hypercalcemia and hypocalcemia.

Device Story

Liquid reagent kit containing Arsenazo III, buffer, and surfactant; used for quantitative photometric end-point determination of total calcium. Input: serum, plasma, or urine samples. Operation: sample reacts with Arsenazo III to form blue complex; absorbance measured bichromatically at 650 nm and 700 nm on Beckman SYNCHRON CX3 System. Output: change in absorbance proportional to calcium concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing calcium-related metabolic disorders.

Clinical Evidence

No clinical studies submitted. Performance established via bench testing, including precision (n=60 per sample type), linearity (NCCLS EP6-A), analytical specificity (NCCLS EP7-A), and method comparison against predicate using 82 serum, 84 plasma, and 76 urine specimens. Results show high correlation (slopes 0.973-0.999) and precision (%CV 0.3-4.1%).

Technological Characteristics

Liquid reagent containing Arsenazo III, buffer, and surfactant. Quantitative photometric end-point method. Bichromatic measurement at 650 nm and 700 nm. Linearity 0-15.5 mg/dL. Storage 2-30 °C. Validated per NCCLS EP5-A (precision), EP6-A (linearity), and EP7-A (specificity). Designed for use on Beckman SYNCHRON CX3 System.

Indications for Use

Indicated for the quantitative determination of total calcium in serum, plasma, and urine in adult patients to aid in the diagnosis of hypercalcemia and hypocalcemia. No specific contraindications listed.

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

• HiChem Calcium Reagent for the CX7 (k941764)

Submission Summary (Full Text)

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DEC 27 2004

## 510(k) SUMMARY K040972

#### 1.0 Submitted By:

C.C. Allain, Ph.D. Chief Scientific Officer GenChem, Inc. 471 W. Lambert Road, Ste 107 Brea, CA 92821 Telephone: [phone] FAX: [phone]

#### 2.0 Date of Preparation: June 1, 2004

#### 3.0 Regulatory Information:

- 3.1 Regulation section: 21 CFR § 862.1145 GenChem Calcium Reagent for the Beckman Synchron CX3 System.
- 3.2 Clasification : Class II
- 3.3 Product Code: CJY
- 3.4 Panel: Clinical Chemistry (75)

#### 4.0 Device Description:

GenChem's Calcium reagent is a liquid composed of Arsenazo III and buffer for the quantitative determination of Calcium in serum, plasma and urine on the Beckman Synchron CX3® System.

#### 5.0 Substantial Equivalence Information:

- a. Predicate Device Name: HICHEM Calcium Reagent for the CX3
- b. Predicate K Number: K941764

Comparison with Predicate: The two products have the same intended C. use, chemical principle, composition, analytical range and stability.

### 6.0 Performance Characteristics: All studies were performed on the Beckman CX3 Synchron Analyzer

- 6.1 Precision/Reproducibility:

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Control sera and diluted urine pools were each assayed 3 times per day over 10 days.on a SYNCHRON CX3® System. Estimates of within run and total imprecision were calculated as described in NCCLS publication EP3-T 8

Precision of Total Calcium Recoveries (mg/dL)

| Sample | n | mean | SD | %CV | SD | %CV |
|---------|----|------|------|-----|------|-----|
| Serum 1 | 60 | 7.2 | 0.06 | 0.7 | 0.10 | 1.4 |
| Serum 2 | 60 | 10.6 | 0.05 | 0.5 | 0.09 | 0.9 |
| Serum 3 | 60 | 14.0 | 0.05 | 0.3 | 0.09 | 0.6 |
| Urine 1 | 60 | 4.0 | 0.03 | 0.7 | 0.16 | 4.1 |
| Urine 2 | 60 | 12.7 | 0.06 | 0.5 | 0.13 | 1.0 |

#### 6.2 Linearity/assay reportable range:

Linearity was performed according to NCCLS Guideline EP6-A. Commercially available linearity standards ranging from 0 to 15 mg/dL were analyzed in triplicate on the Beckman CX3® and the results analyzed by the Least Squares method. The results gave a slope of 0.911 with an intercept of 0.34, a standard error of estimate of 0.35 and r2 = 1.000. Samples exceeding these limits should be diluted with normal saline and reanalyzed. Multiply the result by the appropriate dilution factor.

| | | Usable Range | |
|-----------|--------|--------------------|-------------------|
| Specimens | Range | Conventional Units | SI Units |
| All | Normal | 0.1 to 15 mg/dL | 0.5 – 3.75 mmol/L |

#### 6.3 SENSITIVITY

The sensitivity of this method is 0.1 mg/dL and was documented through the repetitive assay of a diluted serum control. The observed sensitivity limit, calculated as three standard deviations of a 21 replicate within run precision study, is 0.05 mg/dL and is below the claimed limit of 0.1 mg/dL.

#### 6.4 Analytical Specificity

Determined according to NCCLS EP7-A. Hemoglobin levels up to 500 mg/dL, Bilirubin levels up to 20 mg/dL, and Lipemia levels up to 1800 mg/dL were tested and did not show any adverse effect on a stock sample with a calcium level of 9.4 mg/dL. Stock solutions of the substance to be tested were prepared at 20x concentrations and 0.5 ml of this stock was placed in a 10 ml volumetric flask and made up to volume with the base pool. The control stock was prepared similarly but with water as the diluent.

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Heparin, Lithium Heparin Ammonium Heparin, and EDTA are acceptable anticoagulants.

### 7.0 Patient Comparison

Serum, plasma, and urine specimens, collected from adult patients, ranging from 0 to 15.2 mg/dL were assayed for total calcium on a SYNCHRON CX3® System using GenChem and Beckman® calcium reagents. Results were compared by least squares linear regression and the following statistics were obtained.

| VALUE | SERUM | PLASMA | URINE |
|---------------|------------|------------|------------|
| Intercept | -0.1 | -0.1 | 0.1 |
| Slope | 0.994 | 0.973 | 0.999 |
| R2 Value | 0.971 | 0.980 | 0.999 |
| N | 82 | 84 | 76 |
| Range (mg/dL) | 7.0 - 10.6 | 7.4 - 10.5 | 0.4 - 15.2 |

#### 8.0 Expected Values/ Reference Range:

The expected values for total calcium are listed below. Use these ranges only as guides. Each laboratory should establish its own normal ranges.

### Normal Ranges

| Specimens | Conventional Units | SI Units |
|--------------|--------------------|--------------------|
| Serum/Plasma | 8.4 - 10.2 mg/dL | 2.10 - 2.55 mmol/L |
| Urine | 100 - 300 mg/day | 2.5 - 7.5 mmol/day |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or a bird in flight, composed of three stylized human profiles facing right. The profiles are stacked vertically, creating a sense of depth and unity.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 27 2004

C.C. Allain, Ph.D. Chief Scientific Officer GenChem, Inc. 471 W. Lambert Road, Suite 107 Brea, CA 92821

Re: k040972

Trade/Device Name: GenChem Calcium, Azo Dye Reagent Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: October 15, 2004 Received: October 15, 2004

Dear Dr. Allain:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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## Page 2 –

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.

Sincerely, yours,

Cornelia B. Lorks

Cornelia B. Rooks, MA Acting 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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# INDICATIONS FOR USE

510(k) Number: K040972

Device Name: GenChem Calcium, Azo Dye Reagent

Indications For Use:

GenChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diseases associated with hypercalcemia and hypocalcemia.

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Albert Satz
Division Sign-Off

Office of In Vitro Diagr Device Evaluation:

5100k K040972