ATAC PAK CPK REAGENT KIT

K012474 · Elan Holdings, Inc. · CGS · Oct 3, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012474
• Device Name: ATAC PAK CPK REAGENT KIT
• Applicant: Elan Holdings, Inc.
• Product Code: CGS · Clinical Chemistry
• Decision Date: Oct 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The ATAC PAK CPK Reagent Kit and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of creatine kinase in serum and plasma. Creatine Kinase measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. 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 CPK Reagent Kit used with ATAC 8000 Random Access Chemistry System; performs quantitative determination of creatine kinase in serum/plasma samples. Principle of operation: kinetic assay measuring rate of increase in absorbance at 340 nm, proportional to creatine kinase activity (NAD to NADH conversion). Used in professional clinical laboratory settings by trained personnel. Output provides creatine kinase concentration (U/L) to assist clinicians in diagnosing/treating myocardial infarction and muscular dystrophies. System supports primary (0-1,635 U/L) and hyperactive (1,317-3,212 U/L) measurement ranges via dilution.

Clinical Evidence

Bench testing only. Linearity established from 4 to 5,200 U/L. Precision studies (n=60-72 per sample) showed within-run CVs of 0.9-1.5% and total CVs of 2.1-3.0%. Method comparison against a competitive reagent (n=232, range 4-1176 U/L) yielded r=0.999 and regression equation y = -6 U/L + 1.012x. Reagent stability documented for 30 days.

Technological Characteristics

In vitro diagnostic reagent kit for kinetic spectrophotometric analysis. Measures absorbance at 340 nm. Operates on ATAC 8000 Random Access Chemistry System. Supports primary and hyperactive (dilution) measurement ranges. Precision and stability validated per NCCLS Guideline EP3-T.

Indications for Use

Indicated for quantitative determination of creatine kinase in serum and plasma of adult patients for diagnosis/treatment of myocardial infarction and muscle diseases (e.g., progressive, Duchenne-type muscular dystrophy). Not for home use.

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Predicate Devices

• Creatine Kinase Reagent Kit, product no. 442635 (Beckman Coulter, Inc.)

Submission Summary (Full Text)

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OCT - 3 2001

élan diagnostics

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K012474

## 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.

SMDA 1970 and 21 CF C 800722
The ATAC PAK CPK Reagent Kit and the ATAC 8000 Random Access Chemiser Jones in the disamosis The ATAC PAK CPA Reagelli Kirano in serum and plasma. Creatine kinas essults are used in the diagnosis. The diagnosi for the quantitiative delemination of creatine thise in sorain as progressive, Duchenne-sype muscular dystrophy. The secultive The secultive and treatment of myocardial intarction and muscle cliseases adolt as progression of NAD to NADH. The Pressulting rate ATAC PAK CPK Reagent delemines creatine shalled the creatine kinase activity in the sample. The ATAC
of increase in absorbance at approximately 340 nm is proportional to the of increase in absorbance at approximately 3-6 inn is properation in the Kinase Reagent Kit, product no. 442635, marketed by Beckman Coulter, Inc. of Brea, CA.

marked of Dookinal. Council Kit and the ATAC 8000 Random Access Chemistry System is shown by the following studies.

The recovery of creatine kinase using the ATAC PAK CPK Reagent is linear from 4 to 1,600 U/L in the primary useded The recovery of creatine knase using the ATAC FAS CLA Now thour hour hos cover of linearity standards which fange and from 1,400 to 5,200 Off in the mypelacer o and in of the both ranges, and the standard error of span the respective ranges. The coentifiation (1 7 appeacher 10 to Contraction statistics, which compare standard recoveries to standard dilution factors in both ranges, are shown below.

Primary Usable Range sy.x = 13.8 U/L, df = 69 range = 0 - 1,635 U/L, r2 = 0.999. Hyperactive Usable Range

range = 1,317 - 3,212 U/L, sy.x = 28.3 U/L, The lower limit of the linear range (4 U/L) is documented through the repetitive assay of a diluted serum control. The

The lower imm of the mean anye (4 OL) is documented through the reporters within un precision study, is 1.2 U/L and is below the claimed limit. book the normal sample volume and the reduced sample volume with hyperactive dilution, is also mothed

df = 39

by the replicate assay of commercially available serum controls. 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 | 46 | 0.7 | 1.5% | 1.4 | 3.0% |
| Serum 2 | 60 | 556 | 5.8 | 1.0% | 16.2 | 2.9% |
| Serum 3 | 60 | 1177 | 11.9 | 1.0% | 33.3 | 2.8% |

| Precision of Creatine Kinase Recoveries in U/L using Hyperactive Dilutions | | | |
|----------------------------------------------------------------------------|--|--|--|
| | | | |

| Sample | n | mean | Within Run | | Total | |
|---------|----|------|------------|------|-------|------|
| | | | 1SD | %CV | 1SD | %CV |
| Serum 1 | 70 | 2202 | 19 | 0.9% | 45 | 2.1% |
| Serum 2 | 72 | 2636 | 29 | 1.1% | 57 | 2.2% |

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K012674

Mixed serum and plasma specimens, collected from adult patients, were assayed for creatine kinase at 37°C using the ATAC 1000 Random Access Chemissry System and another commercially available method. Results were compared by least squares linear regression and the following statistics were obtained.

ATAC 8000 = -6 U/L + 1.012 x Competitive Reagent n = 232 range = 4 - 1176 U/L r = 0.999

The 30 day on board reagent stability claim is documented through the assay of serum controls over the claimed period. In I ho 50 ag on board reagon bacting bann to other in subjective over the test period are less than the greater of 3 U/L or 3% for both the primary usable range and the extended hyperactive dilution range.

Wynn Stork

er of Regulatory Affairs Elan Diagnostics

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized caduceus, which is a symbol of medicine and health.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 3 2001

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

k012474 Re: Trade/Device Name: ATAC PAK CPK Reagent Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: CGS Dated: July 31, 2001 Received: August 2, 2001

Dear Mr. Stocking:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sunce in the encreases)76, the enactment date of the Medical Device Amendments, or to conninered prof to May 20, 1978, are case and 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 I vou may, dicrerere, mains 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 If your device is exassino (tional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 or any I call the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by bections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 noutheation. The I Dr I inamily ssification 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 1 IT you desire spoonly arriver diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in millionally, for questions on the promotion and advertising of your device, [phone]. Traditional [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monthanon on your respond 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 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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K012874

510(k) Number (if known):

KO12474

Device Name:

ATAC PAK CPK Reagent

Indications For Use:

The ATAC PAK CPK Reagent Kit and the ATAC 8000 Random Access Chemistry System are intended for use as a system The ATAC FAK CFX Reagent Kirane HTFC 5000 Ramond Plasma. Creatine Kinase measurements are used in the for the qualitiative determination of creating in order and progressive, Duchenne-type muscular dystrophy.

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

Respectfully,

Wynn Stocking

Wym Stocking Regulatory Affairs Manager Elan Diagnostics

31 July, 2001

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kesia Alexander for Joan Cuper

(Division Sign-Off)
Division of Clinical Laboratory Devices

Division of Clinical Laboratory Devices
510(k) Number K012474

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use __

(Optional Format 1-2-96)