AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112

K070889 · Wallac OY · CGZ · Apr 14, 2008 · Clinical Chemistry

Device Facts

• Record ID: K070889
• Device Name: AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
• Applicant: Wallac OY
• Product Code: CGZ · Clinical Chemistry
• Decision Date: Apr 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1170
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AutoDELFIA® Neonatal IRT L kit is intended for the quantitative determination of human immunoreactive trypsin (ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA® automatic immunoassay system.

Device Story

AutoDELFIA Neonatal IRT L kit is a solid-phase, two-site fluoroimmunometric assay for quantitative IRT measurement in newborn dried blood spots. Device uses direct sandwich technique with two monoclonal antibodies directed against separate antigenic determinants on IRT molecule. Input: dried blood spot specimens on filter paper. Process: specimens react with immobilized monoclonal antibodies and europium-labeled monoclonal antibodies in assay buffer; one-step incubation; Enhancement Solution dissociates europium ions to form fluorescent chelates. Output: fluorescence intensity proportional to IRT concentration. Used in clinical laboratory settings with 1235 AutoDELFIA automatic immunoassay system. Healthcare providers use results as an aid in screening newborns for cystic fibrosis. Kit includes liquid-based, lyophilized standards and controls; requires extra flush step in assay procedure to prevent carry-over.

Clinical Evidence

No clinical trial data provided. Substantial equivalence established via analytical bench testing comparing the new kit (B022-112) to the predicate (B005-112). Metrics include precision (CV% 9.5-11.0), limit of blank (0.18 ng/mL), linearity (13-370 ng/mL), and hook effect (no effect up to 40,000 ng/mL). IRT distribution in newborns was evaluated to confirm clinical performance consistency.

Technological Characteristics

Solid-phase, two-site fluoroimmunometric assay. Uses monoclonal antibodies derived from mice. Standards/controls are buffer-based, lyophilized solutions. Employs time-resolved fluorescence detection. Requires 1235 AutoDELFIA automatic immunoassay system. Includes protease inhibitors for stabilization. Assay procedure includes an automated flush step to prevent carry-over.

Indications for Use

Indicated for quantitative determination of human immunoreactive trypsinogen (IRT) in dried blood spot specimens to aid in screening newborns for cystic fibrosis.

Regulatory Classification

Identification

A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Predicate Devices

• AutoDELFIA Neonatal IRT kit (k003668)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for PerkinElmer. The logo consists of a stylized "P" shape above the company name. The "P" is formed by a vertical bar and an arrow pointing to the right. Below the company name, the word "precisely" is written in a smaller font.

PerkinElmer Life and Analytical Sciences Wallac Oy P.O. Box 10 FIN-20101 Turku, Finland Phone: +358 - (0)2 - 267 8111 Fax: +358 - (0)2 - 267 8357

http://www.perkinelmer.com

# APR 1 4 2008

# 510 (k) SUMMARY

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

The Assigned 510 (k) Number is: k070889

| Submitter: | Wallac Oy<br>Mustionkatu 6<br>20750 Turku, Finland |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Raija Koskivaara<br>RA Manager<br>[e-mail] |
| Date of Summary Prepared: | March 27, 2008 |
| Device Name: | AutoDELFIA Neonatal IRT L kit |
| Classification Name: | Chloride test system<br>(21 CFR § 862.1170 / Product Code CGZ)<br>Trypsin test system<br>(21 CFR § 862.1725 / Product Code JNO) |
| Predicate Device: | AutoDELFIA Neonatal IRT kit<br>510(k) Number: K003668 |
| Device Description: | The AutoDELFIA Neonatal IRT assay is a solid phase, two-site<br>fluoroimmunometric assay based on the direct sandwich technique in which<br>two monoclonal antibodies (derived from mice) are directed against two<br>separate antigenic determinants on the IRT molecule. Standards, controls and<br>test specimens containing IRT are reacted simultaneously with immobilized<br>monoclonal antibodies directed against a specific antigenic site on the IRT<br>molecule and europium -labeled monoclonal antibodies (directed against a<br>different antigenic site) in assay buffer. The assay buffer elutes IRT from the<br>dried blood spots on the filter paper discs. The complete assay requires only<br>one incubation step.<br>Enhancement Solution dissociates europium ions from the labelled antibody<br>into solution where they form highly fluorescent chelates with components of<br>the Enhancement Solution. The fluorescence in each well is the measured.<br>The fluorescence of each sample is proportional to the concentration of IRT in<br>the sample. |

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Image /page/1/Picture/0 description: The image shows the logo for PerkinElmer. The logo consists of a stylized "P" shape with an arrow pointing to the right above the name "PerkinElmer". Below the name, the word "precisely" is written in a smaller font.

The AutoDELFIA Neonatal IRT L kit is intended for the quantitative Intended Use: determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA® automatic immunoassay system. The B022-112 AutoDELFIA Neonatal IRT L kit is compared to our currently Substantial Equivalence: marketed B055-112 AutoDELFIA Neonatal IRT kit (K003668) and is found to be substantially equivalent when considering the following similarities and differences between the two kits: Similarities: The intended use is the same. They are both intended for the quantitative measurement of IRT in blood specimens dried on filter paper used as an aid in screening newborns for cystic fibrosis. -The assay principle is the same. They are both based on the time resolved fluoroimmunoassay principle. They both use the same antibodies. -The analytical performance characteristics of the two kits are equivalent. – The distribution of IRT concentration in newborns is identical. -Differences: The main difference between the two kits is the matrix of kit standards and controls. The standards and controls in the B005-112 kit are dried blood spots on filter paper. In the B022-112 version of the kit the standards and controls are buffer based solutions, which are provided in the kit in the lyophilized form. -To avoid a carry over effect of liquid standards and controls an extra flush step has been added to the assay procedure of the B022-112 kit. As stabilizers protease inhibitors have been added to standards and controls in the B022-112 kit.

The similarities and differences are also shown in the following table:

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Image /page/2/Picture/0 description: The image shows the PerkinElmer logo. The logo consists of a thick vertical bar and a right-pointing triangle above the company name. Below the company name, the word 'precisely' is written in a smaller font.

| | AutoDELFIA Neonatal IRT kit<br>B005-112 (predicate device) | AutoDELFIA Neonatal IRT L<br>kit B022-112 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Quantitative determination of IRT in<br>blood specimens dried on filter paper<br>as an aid in screening newborns for<br>cystic fibrosis | Same |
| Assay principle | Time-resolved fluoroimmunoassay | Same |
| Assay Procedure | Standards and Controls on filter paper<br>are punched into wells | Liquid Standards and Controls are<br>dispensed into wells. Extra flush to<br>avoid a carry over effect |
| Antibodies / Cross reactivity | Monoclonal antibodies derived from<br>mice | Same |
| Standards | 6 levels (Approx. values 0, 25, 50, 100,<br>250 and 500 ng/mL) | Same |
| Controls | 3 levels (Approx. values 40, 70, 120<br>ng/mL) | Same |
| Standards and Control matrix | Blood spots on filter paper | Buffer based solutions lyophilized |
| Tracer | Anti-IRT-Eu tracer | Same |
| Assay Buffer | Neo IRT Assay Buffer | Same |
| Plates | Anti-IRT Microtitration Plates | Same |
| Precision (Total variation) | CV% 9.3 - 10.0 | CV% 9.5 - 11.0 |
| Limit of blank | < 4 ng /mL | 0.18 ng/mL (95^th %tile) |
| Linearity | Not given in the kit insert | Linear range 13 - 370 ng/mL |
| Hook effect | No effect found up to IRT<br>conc. 40.000 ng/ mL | Same |
| IRT distribution in newborns | Mean: 27 ng/mL blood<br>Median: 23 ng/mL blood<br>90^th %tile: 42 ng/mL blood<br>94^th %tile 50 ng/mL blood<br>95^th %tile 52 ng/mL blood<br>96^th %tile 55 ng/mL blood | Mean: 22 ng/mL blood<br>Median: 18 ng/mL blood<br>90^th %tile: 38 ng/mL blood<br>95^th %tile<br>47 ng/mL blood<br>99^th %tile<br>68 ng/mL blood |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## APR 1 4 2008

Wallac Oy Ms. Raija Koskivaara Regulatory Affairs Manager Mustionkatu 6, P.O. Box 10 20750 Turku, Finland

Re: k070889

Trade/Device Name: AutoDelfia® Neonatel IRT L Kit Regulation Number: 21 CFR 862.1170 Regulation Name: Chloride Test System Regulatory Class: Class II Product Code: CGZ, JNO Dated: April 04, 2008 Received: April 07, 2008

Dear Ms. Koskivaara:

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yéan M. Cooper, M.S., D.V.M. 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

K070889

510(k) Number (if known):

Device Name:

AutoDELFIA® Neonatal IRT L kit

Indications For Use:

The AutoDELFIA® Neonatal IRT L kit is intended for the quantitative determination of human immunoreactive trypsin (ogen) (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA® automatic immunoassay system.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

A

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

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Office of In Vito Diagnostic Device Ivaluation and Safe

KD 70889