ELAN ALKALINE PHOSPHATE REAGENT KIT

K991387 · Elan Holdings, Inc. · CJE · May 19, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991387
• Device Name: ELAN ALKALINE PHOSPHATE REAGENT KIT
• Applicant: Elan Holdings, Inc.
• Product Code: CJE · Clinical Chemistry
• Decision Date: May 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Intended Use

Elan ALP Reagent is intended for the quantitative determination of alkaline phosphatase in serum and plasma for the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This reagent is intended to be used on a Beckman® SYNCHRON CX® autoanalyzer in a professional setting or by trained personnel, and is not intended for home use.

Device Story

Elan ALP Reagent is an in vitro diagnostic reagent for quantitative measurement of alkaline phosphatase in serum and plasma. It functions by catalyzing the hydrolysis of p-nitrophenylphosphate to p-nitrophenol; the resulting increase in absorbance at approximately 410 nm is proportional to alkaline phosphatase activity. The device is designed for use on Beckman SYNCHRON CX-5 autoanalyzers by trained laboratory personnel in professional clinical settings. The healthcare provider uses the resulting quantitative values to assist in the diagnosis and management of liver, bone, parathyroid, and intestinal disorders. The reagent is supplied as a kit for use with existing automated analyzer workflows.

Clinical Evidence

Bench testing only. Performance validated via linearity studies (5 U/L to 1000 U/L), precision studies (n=60 per level, SD 1.34-4.13), and method comparison against the predicate (n=158, r²=0.9964). Stability testing confirmed 10-day on-board reagent stability. No clinical patient outcome data provided.

Technological Characteristics

In vitro diagnostic reagent; enzymatic assay (hydrolysis of p-nitrophenylphosphate). Designed for use on Beckman SYNCHRON CX-5 autoanalyzers. Measures absorbance at ~410 nm. Compatible with serum and plasma; compatible with heparin and lithium iodoacetate anticoagulants. 10-day on-board stability.

Indications for Use

Indicated for quantitative determination of alkaline phosphatase in serum and plasma for diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. For professional use only; not for home use.

Regulatory Classification

Identification

An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Predicate Devices

• Beckman® SYNCHRON® Systems ALP Reagent (production no. 442670)

Submission Summary (Full Text)

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K991387

34

MAY 1 9 1000

élan diagnostics

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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 21 CFR 807.92.

Elan ALP Reagent is intended for the quantitative determination of alkaline phosphatasc in serum and plasma
nd plant of the same of any the wide with and interlinal diverder Flan ALP Reagent is intended for the qualificantes news.id, and intestinal disorders.

The Elan ALP Reagent determines alkaline phosphatase by catalyzing the hydrolysis of p-nitrohenythosphate to The Elan ALP Reagent determines alkaline phosphalase of catalyzhig in 1970 - 1991 - 1991
p-nitrophenol. The resulting increase in absorbance at approximately 410 nm is propo phosphatase activity in the sample.

The Elan AIJP Reagent is an adaptation of the AACC and IFCC methods, and is intended for use with the Beckman The Elan ALP Reagent is an adaptation of the AACC and ICC negired manipulations To support this Synchron CX-5 Autoanalyzer, or with analyzers willen ear attemate at other of those instruments.
Iatter use, procedure supplication sheets) will be supplied to the users of t

The Elan ALP Reagent is substantially equivalent to the Beckman® SYNCHRON® Systems ALP Reagent, production The Elan ALP Reagent is substantially equivalent to the Deckner of teenters of based on the same methodology
no. 442670, manufactured by Beckman Instruments, Brea, CA. Doth c no. 442670, manufactured by the hydrolysis of p-nitrophenylphosphate to p-nitrophenol.

The effectiveness of the Elan reagent application for the Beckman" Systems is shown by the The effectiveness of the Elan reagent application of crecovery of ferum controls for on-board
recovery of linearity standards, the precision of control recovery of ferum cont recovery of linearity standards, the precision of control recovery of the records of patient speciments stability claims, the Vandation of chemical was and of Reagent.

The recoveries of alkaline phosphatase using the Elan ALP Reagon on the SYNCHRON CXX ° Systems are linearity range. Regression The recoveries of alkaline phosphatase using ne read which span the linearity range. Regression
from 5 U/L to 1000 U/L as shown by the recovery of linearity stant tartars wh from 5 U/L to 1000 U/L as shown by the recovery of mich is now and standard factors which range from 0 to 1251 U/L, are shown below.

(Elan Recoveries) = 2.788 U/L + 0.990 x (Standard Factors), r2 = 1.000 Sys = 1.148, df = 10

Precision, demonstrated by replicate assays of commercially available control sera and a spiked high control is shown below.

| Specimen | n | mean | within-run SD | total SD |
|----------|----|-----------|---------------|----------|
| low | 60 | 37.5 U/L | 1.34 | 1.36 |
| medium | 60 | 251.4 U/L | 1.38 | 3.70 |
| high | 60 | 740.6 U/L | 4.13 | 15.38 |

510(k) Notification, Elan Alkaline Phosphatase Reagent Kit Elan Diagnostics, Brea, California

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élan diagnostics

Image /page/1/Picture/1 description: The image shows a logo for "élan". The logo features a stylized letter "e" formed by multiple curved lines, with three horizontal lines extending from the left side of the "e". Below the symbol is the word "élan" in a sans-serif font, with an acute accent over the "e". The logo is black and white.

Alkaline phosphatase recoveries of 80 serum specimens and 78 plasma specimens are compared between the Elan and Beckman® AP Reagents on the SYNCHRON CX® Systems. Least squared regression statistics are shown below.

Patients Comparisons: (Elan Results) = - 0.451 U/L + 0.9986 x (Beckman® Results) r2 = 0.9964 = S(x) = 3.059 n = 158

The use of anticoagulants, heparin and lithium iodoacetate are shown to be acceptable chemical additives by comparison of spiked and unspiked serum pools. In all cases, the addition of anticonnulants is less than 1.5 U/I . alkaline phosphatase and statistically insignificant.

The detection limit claim of 5 U/L is documented through the repetitive assay of an alkaline phosphatase standard. The observed detection limit, calculated as three standard deviations of a 30 replicate within ruroprieision study is 1.845 U/I. and is below the claimed limit.

The 10 day on-board reagent stability claim is documented through the assay of serum controls over the claimed periods. In all cases, the changes in alkaline phosphatasc recoveries over the test periods are less than 3 VL 6 6 %

Ralph Belotti

⁵¹⁰⁽k) Notification, Flan Alkaline Phosphatase Reagent Kit Elan Diagnostics, Brea, California

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Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. 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 image of an eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

MAY 1 9 1990

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Ralph Bolstad Senior R & D Chemist Elan Diagnostics 231 North Puente Street Brea, California 92821

Rc: K991387

> Trade Name: Elan Alkalinc Phosphate Reagent Kit Regulatory Class: II Product Code: CJE Dated: April 19, 1999 Reccived: April 21, 1999

Dear Mr. Bolstad:

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 misbranding and adultcration.

If your device is classified (sec above) into cither 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic Q1 inspections, the Food and Drug Administration (FDA) will verify such assumptions. Tailure (o comply with the GMP regulation may result in regulatory 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

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may
1988 (Clinical Laborators areassizetion - To determine if it does, you should c Under the Clinical Laboratory Improvement Amendiments of 1 706 (OEIF 2017)
require a CLIA complexity categorization. To determine if it does, you should contact the first require a CLIA complexity categorization: 16 accential
Centers for Disease Control and Prevention (CDC) at [phone].

Chiels in Lisease obla This letter will allow you to begin marketing your device to a legally harketed on Algally marketed
notification. The FDA finding of substantial equivalence of your device t notification. The FDA finding of substantial equivalence of your device and thus, permits your device to proceed to the market.

proceded on the for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your device on our labeling regulation (2) Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the If you desire open in vite dagnostic devices), please contact me of your device,
[phone]. Al or in xitte diagnostic devices), please not the regulation [phone]. Additionally, for questions on the promotion and at were and [phone]. Premience at [phone]. Also, please note more in estable in estable in elemental
entitled, "Misbranding by reference to premarket mor be obtained fro pressed on the mail on reference to premarket motification (1) CLFK of From the Division of Small
entitled, "Misbranding by reference to premarked from the Division of Small entitude, Tresponsibilities under the Act may be oblamber [phone], or at its
Manufacturers Assistance at its toll-free number [phone] or [phone], or at Manufacturers Assistance at its ton-free hands in ("." ")
internet address "http://www.fda.gov/cdrlv/dsmaldsmamain.html".

Sincerely yours,

Steven Putman

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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510(k) Number (if known):

Page 1 of 1

Device Name: Elan ALP Reagent Kit

Indications For Use:

Elan ALP Reagent is intended for the quantitative determination of alkalinc phosphatasc in serum and plasma for the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

This reagent is intended to be used on a Beckman® SYNCHRON CX ® autoanalyzer in a professional setting or by trained personnel, and is not intended for home use.

Respectively,

Ralph Bolstad Senior R&D Chemist Elan Diagnostics

19 April, 1999

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991387

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use

(Optional Format 1-2-96)