ATAC PAK PHOSPHORUS REAGENT

K030015 · Elan Diagnostics · CEO · Mar 7, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030015
• Device Name: ATAC PAK PHOSPHORUS REAGENT
• Applicant: Elan Diagnostics
• Product Code: CEO · Clinical Chemistry
• Decision Date: Mar 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1580
• Device Class: Class 1

Intended Use

The ATAC PAK Phosphorus Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Device Story

ATAC PAK Phosphorus Reagent Kit is an in vitro diagnostic reagent for use on the ATAC 8000 Random Access Chemistry System. It measures inorganic phosphorus in serum and plasma samples. Principle of operation: phosphorus reacts with molybdate to form a phosphomolybdate complex; the resulting increase in absorbance at 340 nm is measured photometrically and is proportional to phosphorus concentration. Used in professional clinical laboratory settings by trained personnel. Output is a quantitative phosphorus concentration value (mg/dL) used by clinicians to diagnose and manage metabolic disorders related to parathyroid, kidney, and vitamin D function.

Clinical Evidence

Bench testing only. Linearity established from 0.1 to 15 mg/dL. Precision studies (n=60 per sample) showed within-run CVs of 2.3-3.2% and total CVs of 3.5-5.0%. Method comparison against a competitive reagent (n=115, range 0.9-9.6 mg/dL) yielded a Deming regression of y = -0.17 + 1.001x. Detection limit is 0.1 mg/dL. Onboard reagent stability (14 days) and calibration stability (7 days) were verified.

Technological Characteristics

Reagent-based photometric assay; molybdate reaction chemistry. Measures absorbance at 340 nm. Designed for use on the ATAC 8000 Random Access Chemistry System. Quantitative, automated clinical chemistry analyzer platform.

Indications for Use

Indicated for quantitative determination of inorganic phosphorus in serum and plasma for diagnosis and treatment of parathyroid gland disorders, kidney diseases, and vitamin D imbalance in adult patients. Not for home use.

Regulatory Classification

Identification

A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Predicate Devices

• Beckman Synchron Phosphorus Reagent (product 465145)

Submission Summary (Full Text)

{0}------------------------------------------------

K030015

MAR 0 7 2003

Image /page/0/Picture/2 description: The image shows the word "élan" in a stylized font. The "é" has a textured design above it, resembling a brushstroke or abstract mark. The rest of the word "lan" is written in a simple, elegant typeface, contrasting with the more decorative "é".

1075 W. Lambert Road Building D Brea, California 92821 T [phone] F [phone]

## SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION

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.

The ATAC PAK Phosphorus Reagent Kit is intended for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. The ATAC PAK Phosphorus Reagent determines phosphorus through its reaction with molybdate to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.

The ATAC PAK Phosphorus Reagent Kit is substantially equivalent to the Beckman Synchron Phosphorus Reagent, product 465145, which is currently marketed by Beckman Coulter, Inc. of Brea, CA. The effectiveness of ATAC PAK Phosphorus Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.

The recovery of inorganic phosphorus using the ATAC PAK Phosphorus Reagent is linear from 0.1 to 15 mg/dL. as shown by the recovery of linearity standards that span the usable range. Regression statistics compare stoneries to standard values. These statistics are shown below.

$$\text{(ATAC Recoveries)} = -0.05 \text{ mg/dL} + 0.991 \times \text{(Standard Value)}, \quad \text{r} = 1.000, \quad \text{s}_{\text{Y}\text{X}} = 0.11 \text{ mg/dL}, \quad \text{n} = 27\% \text{ of the rod}$$

Precision is demonstrated by the replicate assay of commercially available control serum. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.

| Sample | n | mean | Within Run | | Total | |
|---------|----|------|------------|------|-------|------|
| | | | 1SD | %CV | 1SD | %CV |
| Serum 1 | 60 | 1.8 | 0.06 | 3.2% | 0.09 | 5.0% |
| Serum 2 | 60 | 4.3 | 0.10 | 2.3% | 0.15 | 3.5% |
| Serum 3 | 60 | 6.7 | 0.15 | 2.3% | 0.23 | 3.5% |

Mixed serum and plasma specimens, collected from adult patients, were assayed for inorganic phosphorus using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.

ATAC 8000 = -0.17 mg/dL + 1.001 x Competitive Reagent sv.x= 0.17 mg/dL n = 115 range = 0.9 - 9.6 mg/dL

The detection limit of 0.1 mg/dL is documented through the repetitive assay of a diluted serum pool. The observed standard deviation of a 30 replicate within run precision study was 0.049 mg/dL. Consequently, the detection limit is reported as 0.1 mg/dL, which is the round-off error of the assay.

The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of phosphorus over the test periods are less than 0.2 mg/dL or 4%.

Wynn Stocking

Wynn Stocking Manager of Regulatory Affairs Elan, Brea California

510(k) Notification, ATAC PAK Phosphorus Reagent Kit, 31 December, 2002, p 63

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. The logo is rendered in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 0 7 2003

Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 1075 W. Lambert Road - Building D Brea. CA 92821

> k030015 Trade/Device Name: ATAC PAK Phosphorus Reagent Regulation Number: 21 CFR 862.1580 Regulation Name: Phosphorus (inorganic) test system Regulatory Class: Class I Product Code: CEO Dated: December 31, 2002 Received: January 2, 2003

Dear Mr. Stocking:

Re:

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. Iisting 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).

{2}------------------------------------------------

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 yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

KosoonS

510(k) Number (if known):

Device Name:

ATAC PAK Phosphorus Reagent

Indications for Use:

The ATAC PAK Phosphorus Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jean Coope
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K630015

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Format 1-2-96)