NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT

K021541 · Perkinelmer Life Sciences · JNB · Oct 28, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021541
• Device Name: NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
• Applicant: Perkinelmer Life Sciences
• Product Code: JNB · Clinical Chemistry
• Decision Date: Oct 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1555
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The NeoGram PKU Tandem Mass Spectrometry Kit is intended for screening for Phenvlketonuria (PKU). It involves the quantitative determination of phenvlalanine, tyrosine and the phenylalanine to tyrosine ratio (Phe/Tyr) in blood specimens dried on filter paper. This will aid in identifying newborns with PKU. It is intended for use by trained, qualified laboratory personnel.

Device Story

Kit extracts amino acids from dried blood spots on filter paper using isotopically labeled internal standards; methanol/water extraction solution. Analysis performed on tandem mass spectrometer. Device quantifies phenylalanine, tyrosine, and Phe/Tyr ratio. Used in clinical laboratory settings by trained personnel. Output provides quantitative concentration data to aid clinicians in identifying newborns with PKU.

Clinical Evidence

Bench testing only. Comparative study of 3,679 samples analyzed by both fluorometric method and NeoGram TMS method. Results: Fluorometric mean 1.1 mg/dl (S.D. 0.3); TMS mean 1.1 mg/dl (S.D. 0.2).

Technological Characteristics

In vitro diagnostic kit; utilizes tandem mass spectrometry (TMS) for analyte quantification. Employs 96-well microtiter plates. Sample input: 3mm punched dried blood spot. Extraction: methanol/water solution. Detection: mass spectrometric assay using isotopically labeled internal standards.

Indications for Use

Indicated for screening newborns for phenylketonuria (PKU) via quantitative determination of phenylalanine, tyrosine, and Phe/Tyr ratio in dried blood spot specimens.

Regulatory Classification

Identification

A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.

Predicate Devices

• Isolab Phenylalanine Test Kit

Submission Summary (Full Text)

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

### OCT 2 8 2002

#### 510(k) Summary

This summary of 510(k) safety and effectiveness information is being in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92.

The assigned 510(k) number is:________________________________________________-

Date: 3/28/01

Submitted by: PerkinElmer Life Sciences 3985 Eastern Rd. Norton, OH 44203

Telephone: [phone] Fax: [phone]

Contact person: Hank Juske, Director, Regulatory Affairs

Trade name: NeoGram PKU Tandem Mass Spectrometry Kit (MS-7960) Common name: Phenylalanine screening test kit Classification name: Phenylalanine test system

Legally marketed predicate device: Isolab Phenylalanine Test Kit

Device description: The assay involves the extraction of dried blood spots with a solution containing stable, isotopically labeled internal standards. The response of each amino acid relative to the isotopically labeled standards in the kit is proportional to their actual concentration. The analysis of the material is performed on a tandem mass spectrometer. Control material contained in the kit allows for verification of performance for the test run.

Intended use: The NeoGram PKU Tandem Mass Spectrometry Kit is intended for screening for Phenvlketonuria (PKU). It involves the quantitative determination of phenvlalanine, tyrosine and the phenylalanine to tyrosine ratio (Phe/Tyr) in blood specimens dried on filter paper. This will aid in identifying newborns with PKU. It is intended for use by trained, qualified laboratory personnel.

Similarities/ Differences with the predicate device:

| Similarities: |
|---------------------------------------------------------------------|
| -Intended use is the same. Both kits are for screening of newborns. |
| -Both kits are intended to screen for the defect PKU. |
| -Both measure the analyte Phenylalanine |
| -Both use dried blood spots on filter paper for sample collection |
| -Both use standards and controls dried onto filter paper |
| -Both assays are quantitative |
| -Sample size (3mm punched spot) is the same |
| -Both employ a 96 well microtiter plate |

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

-Fluorometric based chemistry vs. spectrometric assay Differences: -Linearity of approximately 21mg/dl fluorometric vs. 35 mg/dl TMS -Measurement by calibration curve versus internal standard comparison -Zinc sulfate/ethanol extraction solution vs. methanol / water solution

Mean value/ standard deviation of 3679 samples run by:

Fluorometric method: X= 1.1 mg/dl S.D.= 0.3

Tandem Mass Method: X= 1.1 mg/dl S.D = 0.2

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## OCT 2 8 2002

Ms. Carroll Martin Regulatory Affairs Manager PerkinElmer Life Sciences, Inc. 3985 Eastern Road Norton, Ohio 44203

Re: k021541

> Trade/Device Name: NeoGram PKU Tandem Mass Spectrometry Kit Regulation Number: 21 CFR 862.1555 Regulation Name: Phenylalanine test system Regulatory Class: Class II Product Code: JNB; CDR; JJE Dated: August 21, 2002 Received: August 22, 2002

Dear Ms. Martin:

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 adultcration.

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 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 comply with all 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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

#### 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman

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

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for PerkinElmer life sciences. The logo consists of a stylized "P" shape, with a thick vertical bar and an arrow-like shape pointing to the right. Below the symbol is the text "PerkinElmer" in a bold, sans-serif font. Underneath "PerkinElmer" is the text "life sciences." in a smaller, lighter font.

PerkinElmer Life Sciences 3985 Eastern Rd. Norton, OH 44321 Phone: [phone] Fax[phone] http://www.perkinelmer.com

# INDICATIONS FOR USE STATEMENT

510(K) Number K021541

Device name: NeoGram PKU Tandem Mass Spectrometry Kit

Indications for use: The kit is intended for screening for phenylketonuria (PKU). It involves the quantitative determination of phenylalanine, tyrosine and the phenylalanine to tyrosine ratio (Phe/Tyr) in blood specimens dried on filter paper. This will aid in identifying newborns with PKU. It is intended for use by trained, qualified laboratory personnel.

San Cooper

(Division Sign-Off)

Division of Clinical Laboratory Devices K 8 21 54 510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Prescription Use (per 21 CFR 801.109)

Over-the-Counter Use

| (Division Sign-Off) | |
|-----------------------------------------|--|
| Division of Clinical Laboratory Devices | |

Division of Clinical Laboratory Devices
510(k) Number K061541