AUTODELFIA NEONATAL IRT KIT

K110274 · Wallac Oy, A Subsidiary of Perkinelmer, Inc. · JNO · Jun 10, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110274
• Device Name: AUTODELFIA NEONATAL IRT KIT
• Applicant: Wallac Oy, A Subsidiary of Perkinelmer, Inc.
• Product Code: JNO · Clinical Chemistry
• Decision Date: Jun 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1725
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The AutoDELFIA Neonatal IRT 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

The AutoDELFIA Neonatal IRT kit is an in vitro diagnostic assay for newborn screening of cystic fibrosis. It utilizes dried blood spot samples collected on filter paper. The device employs a solid-phase, two-site fluoroimmunometric sandwich assay. Monoclonal antibodies (mouse-derived) are used: one immobilized on microtitration strips and one europium-labeled. The assay buffer elutes IRT from the blood spot; a single incubation step occurs. An Enhancement Solution dissociates europium ions, forming fluorescent chelates. The 1235 AutoDELFIA automatic immunoassay system measures the resulting fluorescence, which is proportional to IRT concentration. The device is used in clinical laboratory settings by trained personnel. Results assist healthcare providers in identifying newborns at increased risk for cystic fibrosis, facilitating selection for second-tier testing. The system provides quantitative IRT levels to support screening programs.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by analytical bench testing, including precision studies (CV% 8.0-9.6 across various concentrations), linearity, analytical sensitivity (Limit of Blank 0.53 ng/mL, Limit of Detection 2.9 ng/mL), and cross-reactivity assessments against potential interferents (e.g., alpha-1-antitrypsin, phospholipase A2, chymotrypsin, human IgG).

Technological Characteristics

Solid-phase, two-site fluoroimmunometric sandwich assay. Uses mouse monoclonal antibodies. Detection via time-resolved fluorescence. Specimen: 3.2 mm dried blood spot on filter paper (Whatman no. 903). Instrument: 1235 AutoDELFIA. Reagents include Tris-HCl buffered assay buffer (pH 7.8) with BSA and protease inhibitors. Calibration: 6-level gravimetric. Controls: 3-level. Measuring range: 16-480 ng/mL. No hook effect up to 40,000 ng/mL.

Indications for Use

Indicated for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in dried blood spot specimens from newborns as an aid in screening for cystic fibrosis.

Regulatory Classification

Identification

A trypsin test system is a device intended to measure the activity of trypsin (a pancreatic enzyme important in digestion for the breakdown of proteins) in blood and other body fluids and in feces. Measurements obtained by this device are used in the diagnosis and treatment of pancreatic disease.

Predicate Devices

• Wallac Oy AutoDELFIA Neonatal IRT kit (k003668)

Submission Summary (Full Text)

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K110274

## 510(k) SUMMARY

JUN 1 0 2011

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 Assigned 510(k) Number is:

Date: January 26, 2010

Submitted by:

Wallac Oy, subsidiary of PerkinElmer 940 Winter Street Waltham, MA 02451 USA

Contact Person: Primary:

Susan K. Hamann Tel: [phone] Fax: [phone]

Kay A. Taylor

JNO

Tel: [phone] Fax: [phone]

Secondary:

Trade Name:

Common Name: Regulation:

AutoDELFIA Neonatal IRT kit 21 CFR 862.1725

Trypsin Test System and Electrode

Classification Name:

Product Code:

Predicate Device:

Device Description:

AutoDELFIA® Neonatal IRT kit, B005-112

AutoDELFIA® Neonatal IRT kit B005-212, B005-204

510(k) Number (K0003668)

The AutoDELFIA Neonatal IRT assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the IRT molecule. Calibrators, controls and test specimens containing IRT are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the IRT molecule and europium-labeled monoclonal antibodies (directed against a different antigenic site) in assay buffer. The assay buffer elutes IRT from the dried blood on filter paper disks. The complete assay requires only one incubation step.

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Enhancement Solution dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of IRT in the sample.

The AutoDELFIA Neonatal IRT 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.

Substantial Equivalence: The AutoDELFIA Neonatal IRT kit (B005-212/B005-204) is substantially equivalent to the currently marketed AutoDELFIA IRT kit (B005-112) (K0003668). There are the following similarities and differences between the two kits:

Intended Use:

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Table 1. Characteristics of the two kits.

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| Characteristic (Feature) | AutoDELFIA Neonatal<br>IRT kit<br>B005-212/B005-204<br>(New Device) | AutoDELFIA Neonatal<br>IRT kit<br>B005-112<br>(Predicate Device) |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended User | Adequately trained laboratory<br>personnel in laboratories<br>performing newborn<br>screening | Same |
| Intended Use / Indications for Use | The AutoDELFIA Neonatal<br>IRT kit (B005-212/B005-204)<br>is intended for the quantitative<br>determination of human<br>immunoreactive trypsin(ogen)<br>(IRT) in blood specimens<br>dried on filter paper as an aid<br>in screening newborns for<br>cystic fibrosis using the 1235<br>AutoDELFIA® automatic<br>immunoassay system. | The AutoDELFIA Neonatal<br>IRT (B005-112) is intended<br>for the quantitative<br>determination of human<br>immunoreactive trypsin (IRT)<br>in blood specimens dried on<br>filter paper as an aid in<br>screening newborns for cystic<br>fibrosis using the 1235<br>AutoDELFIA® automatic<br>immunoassay system. |
| Chemical Principle | The AutoDELFIA Neonatal<br>IRT assay is a solid phase,<br>two-site fluorimmunometric<br>assay based on the direct<br>sandwich technique in which<br>two monoclonal antibodies<br>(derived from mice) are<br>directed against two separate<br>antigenic determinants on the<br>IRT molecule. Calibrators,<br>controls, or test specimens<br>containing IRT are reacted<br>simultaneously with<br>immobilized monoclonal<br>antibodies directed against a<br>specific antigenic site on the<br>IRT molecule and europium-<br>labeled monoclonal antibodies<br>(directed against a different<br>antigenic site) in assay buffer.<br>The assay buffer elutes IRT<br>from dried blood on filter<br>paper disks. The complete<br>assay requires only one<br>incubation step. | Same |
| Characteristic (Feature) | AutoDELFIA Neonatal<br>IRT kit<br>B005-212/B005-204<br>(New Device) | AutoDELFIA Neonatal<br>IRT kit<br>B005-112<br>(Predicate Device) |
| | from the labeled antibody into solution where they form<br>highly fluorescent chelates with components of the<br>Enhancement Solution. The fluorescence in each well is<br>then measured. The fluorescence of each sample is<br>proportional to the<br>concentration of IRT in the sample. | |
| Detection principle | Time-resolved fluorescence | Same |
| Specimen | Dried blood on filter paper<br>disks with a diameter of<br>approximately 3.2 mm (1/8<br>inch) | Same |
| Antibodies | Two different mouse<br>monoclonal antibodies | Same |
| Calibrator and Control Matrix | Human blood derivative with<br>a hematocrit of 50-55% and<br>spotted onto filter paper<br>(Whatman, no. 903) | Same |
| | (Washed blood cells in buffer<br>containing BSA and protease<br>inhibitors)<br>(Filter paper on a supportive<br>frame called "cassette") | (Washed blood cells in saline<br>containing saccharose)<br>(Filter paper as sheets) |
| Kit Calibrators | 6 levels.<br>(approx. values 0, 25, 50, 100,<br>250, 500 ng/mL blood. | Same |
| Kit Controls | 3 levels (approx. values 30, 70<br>and. 110 ng/mL blood) | 3 levels (approx. values 40,<br>70 and 120 ng/mL blood) |
| Calibration | Calibrated using gravimetric<br>methods | Same |
| | (In-house calibrators contain<br>protease inhibitors and BSA<br>item 1.) | (In-house calibrators without<br>protease inhibitors, contain<br>BSA item 2.) |
| Assay buffer | IRT Assay Buffer, ready for<br>use<br>Tris-HCl buffered (pH 7.8)<br>salt solution with bovine<br>serum albumin, and additives. | Same |
| Characteristic (Feature) | AutoDELFIA Neonatal<br>IRT kit<br>B005-212/B005-204<br>(New Device)<br>(BSA item 1 used) | AutoDELFIA Neonatal<br>IRT kit<br>B005-112<br>(Predicate Device)<br>(BSA item 2 used) |
| Coated Plates | Anti-IRT Microtitration<br>Strips, 8 X 12 wells coated<br>with antibodies directed<br>against a specific site on the<br>IRT molecule (mouse<br>monoclonal) | Same |
| Tracer | Anti-IRT-Eu tracer stock<br>solution (~50 µg/mL), mouse<br>monoclonal, ready for use. . | Same |
| Instrument | 1235 AutoDELFIA Instrument | Same |
| Dissociation solution | Enhancement Solution | Same |
| Expected Values | The measurement of IRT<br>from dried blood spots is used<br>as a means of identifying a<br>population of newborns who<br>are at increased risk of having<br>CF and should be selected for<br>2nd tier testing. The<br>identification is based on the<br>use of a fixed cut-off value or<br>population percentile. The<br>IRT cut-off levels must be<br>determined by each newborn<br>screening laboratory to meet<br>the desired sensitivity and<br>specificity of the screen and<br>should be evaluated<br>periodically. | Same |
| Measuring Range | 16 to 480 ng/mL blood<br>Linearity Range: 16 to 480<br>ng/mL blood | 4(as defined by LoB) to 500 (as<br>defined by upper calibrator)<br>ng/mL blood<br>Linearity Range: No claims for<br>linearity in labeling. |
| Analytical Sensitivity / Limit of<br>Blank, | Limit of Blank<br>0.53 ng/mL blood | Limit of Blank<br>< 4 ng/mL blood |
| Limit of Detection | Limit of Detection<br>2.9 ng/mL blood | |
| Antibody<br>Cross-Reactions<br>in the Assay | α2-macroglobulin < 4 ng/ml<br>blood<br>al-antitrypsin < 4 ng/ml blood<br><br>Phospholipase A2 < 4 ng/ml<br>blood<br>Chymotrypsin < 4 ng/ml blood | Same |
| Characteristic (Feature) | AutoDELFIA Neonatal<br>IRT kit<br>B005-212/B005-204 | AutoDELFIA Neonatal<br>IRT kit<br>B005-112 |
| | (New Device) | (Predicate Device) |
| | Human IgG < 4 ng/ml blood<br>Uropepsinogen < 4 ng/ml blood | |
| Hook effect | No hook effect has been<br>found with IRT<br>concentrations up to 40,000<br>ng/mL | Same |
| Precision (Total Variation using<br>a full calibration curve on each<br>plate) | 16.7 ng/mL blood CV% 8.7<br>22.5 ng/mL blood CV% 9.6<br>48.0 ng/mL blood CV% 9.1<br>104 ng/mL blood CV% 8.0<br>247 ng/mL blood CV% 8.3<br>401 ng/mL blood CV% 8.4<br>449 ng/mL blood CV% 9.4 | 42.6 ng/mL blood CV% 9.3<br>98.8 ng/mL blood CV% 10.0<br>266 ng/mL blood CV% 9.6 |

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Image /page/6/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Wallac Oy A Subsidiary of PerkinElmer, Inc. c/o Ms. Susan K. Hamann Regulatory Affairs Manager 940 Winter Street Waltham, MA 02451

10 2011

Re: k110274 Trade Name: AutoDELFIA® Neonatal IRT Kit Regulation Number: 21 CFR 862.1725 Regulation Name: Trysin test system. Regulatory Class: I exempt, exceeds the limitation to exemption in 862.9(c) (2) Product Codes: JNO Dated: May 05, 2011 Received: May 06, 2011

Dear Ms. Susan K. Hamann:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 no mber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

Courtney Harper, Ph.D. 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 Form

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: AutoDELFIA Neonatal IRT kit (B005-212)

Indications for Use:

The AutoDELFIA Neonatal IRT 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 OF NEEDED)

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

Rus

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110274