GSP NEONATAL IRT KIT (3306-001U)

K102419 · Wallac Oy, Subsidiary of Perkinelmer · JNO · Dec 16, 2010 · Clinical Chemistry

Device Facts

• Record ID: K102419
• Device Name: GSP NEONATAL IRT KIT (3306-001U)
• Applicant: Wallac Oy, Subsidiary of Perkinelmer
• Product Code: JNO · Clinical Chemistry
• Decision Date: Dec 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1725
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The GSP Neonatal IRT kit is intended for the quantitative determination of human immunoreactive trypsin(ogen) in blood specimens dried on filter paper as an aid in screening newborns for Cystic Fibrosis using the GSP® instrument.

Device Story

The GSP Neonatal IRT kit is a quantitative immunoassay for measuring immunoreactive trypsin (IRT) in dried blood spots (DBS) from newborns. The device uses a solid-phase, two-site fluoroimmunometric assay (direct sandwich technique) with two mouse monoclonal antibodies directed against separate antigenic determinants on the IRT molecule. One antibody is immobilized on microtitration strips, while the other is europium-labeled. The assay is performed on the GSP instrument, which automates the incubation and measurement process. After incubation, a DELFIA Inducer dissociates europium ions to form fluorescent chelates; the resulting fluorescence is proportional to the IRT concentration. The device is used in clinical laboratory settings to identify newborns at increased risk for cystic fibrosis, typically as part of a multi-tier screening program. Healthcare providers use the quantitative output to determine if a newborn requires follow-up testing (e.g., DNA analysis or repeat IRT). This screening helps facilitate early identification and intervention for infants with cystic fibrosis.

Clinical Evidence

Bench testing only. Performance was evaluated using 1,945 clinical specimens (1,925 routine screening, 20 confirmed CF positive). Method comparison against the predicate showed 97.8% overall agreement at the 95th percentile cut-off and 99.5% at the 99th percentile. Precision studies (CLSI EP5-A2) demonstrated total CVs ranging from 7.0% to 8.5% across the measuring range (9–500 ng/mL). Analytical sensitivity (LoB 0.76 ng/mL, LoD/LoQ 2.2 ng/mL) and linearity were established. Interference testing (CLSI EP7-A2) confirmed no significant interference from bilirubin, hemoglobin, or triglycerides.

Technological Characteristics

Solid-phase, two-site fluoroimmunometric assay. Detection: Time-resolved fluorescence. Materials: Mouse monoclonal antibodies, Whatman no. 903 filter paper cassettes. Energy: Fluorescence excitation/measurement via GSP instrument. Connectivity: GSP instrument-based. Sterilization: Not applicable (reagent kit).

Indications for Use

Indicated for quantitative determination of human immunoreactive trypsin(ogen) 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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510(k) SUMMARY

- 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: K102419

Date: December 9, 2010

Submitted by: Wallac Oy, subsidiary of PerkinElmer 940 Winter Street Waltham, MA 02451 USA Contact Person: Susan K. Hamann Primary: Tel: [phone] Fax: [phone] Kay A. Taylor Secondary: Tel: [phone] Fax: [phone] Trade Name: GSP® Neonatal IRT kit (3306-001U) Common Name: GSP Neonatal IRT kit Regulation: 21 CFR 862.1725 Classification Name: Trypsin Test System Product Code: JNO AutoDELFIA® Neonatal IRT kit, Predicate Device: 510(k) Number (K0003668) Device Description: The GSP 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 or 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 dried blood on filter paper disks. The

complete assay requires only one incubation step.

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

Intended Use:

The GSP Neonatal IRT kit is intended for the quantitative determination of IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the GSP® instrument.

.Substantial Equivalence:

The GSP Neonatal IRT kit is substantially equivalent to our currently marketed - AutoDELFIA - IRT kit (K0003668). There are the following similarities and differences between the two kits:

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Table 1. Characteristics of the two kits.

| Characteristic | GSP Neonatal IRT kit<br>(New Device) | AutoDELFIA Neonatal IRT kit<br>(Predicate Device) | |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Similarities | | | |
| Intended User | Adequately trained laboratory personnel in laboratories performing newborn screening | Same | |
| Intended Use / Indications for Use | The GSP Neonatal IRT kit is intended for the quantitative determination of IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the GSP® instrument. | The AutoDELFIA Neonatal IRT kit is intended for the quantitative determination of human IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA automatic immunoassay system. | |
| Chemical Principle | The GSP Neonatal IRT assay is a solid phase, two-site fluorimmunometric 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, or 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 dried blood on filter paper disks. The complete assay requires only one incubation step.<br>DELFIA Inducer dissociates europium ions from the | Same | |
| Characteristic | GSP Neonatal<br>IRT kit<br>(New Device) | AutoDELFIA Neonatal<br>IRT kit<br>(Predicate Device) | |
| | fluorescent chelates with<br>components of the DELFIA<br>Inducer. The fluorescence in<br>each well is then measured.<br>The fluorescence of each<br>sample is proportional to the<br>concentration of IRT in the<br>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>cassettes (Whatman, no. 903) | Same | |
| | (Washed RBCs in buffer<br>containing BSA and protease<br>inhibitors) | (Washed RBCs in buffer<br>containing saccharose) | |
| Calibration | Calibrated using gravimetric<br>methods | Same | |
| Controls | 3 levels (approx. values 30, 70<br>and 110 ng/mL blood) | Same | |
| Assay buffer | IRT Assay Buffer, ready for<br>use | Same | |
| | Containing blockers and BSA<br>item 1 | Containing BSA item 2 | |
| Calibrators | 6 levels<br>(approx. values 0, 25, 50, 100,<br>250, 500 ng/mL blood) | 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 | Same | |
| Characteristic | GSP Neonatal<br>IRT kit | AutoDELFIA Neonatal<br>IRT kit | |
| | (New Device) | (Predicate Device) | |
| | 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. | | |
| 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 | |
| | Microtitration plate raw<br>material item 1. | Microtitration plate raw<br>material item 2 | |
| Characteristic | GSP Neonatal<br>IRT kit<br>(New Device) | Differences | AutoDELFIA Neonatal<br>IRT kit<br>(Predicate Device) |
| Instrument | GSP Instrument | | 1235 AutoDELFIA Instrument |
| Dissociation solution | DELFIA Inducer | | Enhancement Solution |
| Antibody<br>Cross-Reactions<br>in the Assay | α2-macroglobulin | 0.000% | α2-macroglobulin < 4 ng/ml<br>blood |
| | α1-antitrypsin | 0.000% | α1-antitrypsin < 4 ng/ml blood |
| | Phospholipase A2 | 0.014% | Phospholipase A2 < 4 ng/ml<br>blood |
| | Chymotrypsin | 0.959% | Chymotrypsin < 4 ng/ml blood |
| | Human IgG | 0.000% | Human IgG < 4 ng/ml blood |
| | Pepsinogen | -0.056% | (Uro)Pepsinogen < 4 ng/ml blood |
| | Complement Factor I | 0.000% | Complement Factor I NA |
| Measuring Range | 9 to 500 ng/mL blood | | 4(as defined by LoB) to 500 (as<br>defined by upper calibrator)<br>ng/mL blood |
| | Linearity Range: 9 to500 ng/mL<br>blood | | Linearity Range: No claims for<br>linearity in labeling. |
| Tracer | Anti-IRT-Eu tracer stock<br>solution, approximate<br>concentration of<br>~40 µg/ml mouse monoclonal | | Anti-IRT-Eu tracer stock<br>solution, approximate<br>concentration of<br>~50 µg/ml mouse monoclonal |

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| | ready for use. | ready for use. |
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| | Tracer antibody labeling with<br>europium-chelate 1 | Tracer antibody labeling with<br>europium-chelate 2 |
| | | Contains mouse IgG as blocker. |
| Analytical Sensitivity / Limit of<br>Blank, | Limit of Blank<br>0.76 ng/mL blood | Limit of Blank<br>< 4 ng/mL blood |
| Limit of Detection | Limit of Detection<br>2.2 ng/mL blood | |
| Limit of Quantitation | Limit of Quantitation<br>2.2 ng/mL blood | |
| Precision (Total Variation using<br>a full calibration curve on each<br>plate) | 10.9 ng/mL blood CV% 7.3 | 42.6 ng/mL blood CV% 9.3 |
| | 22.2 ng/mL blood CV% 7.2 | 98.8 ng/mL blood CV% 10.0 |
| | 28.5 ng/mL blood CV% 7.0 | 266 ng/mL blood CV% 9.6 |
| | 40.0 ng/mL blood CV% 8.2 | |
| | 50.2 ng/mL blood CV% 8.0 | |
| | 61.6 ng/mL blood CV% 7.8 | |
| | 93.5 ng/mL blood CV% 7.2 | |
| | 302.3 ng/mL blood CV% 7.4 | |
| | 449 ng/mL blood<br>CV% 7.5 | |

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Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Wallac Ov. Subsidiary of Perkin Elmer Inc. c/o Ms. Susan K. Hamann Regulatory Affairs Manager 940 Winter Street Waltham. MA 02451

Food & Drug Administration 10903 New Hamoshire Avenue Building 66 Silver Spring, MD 20993

DEC 1 6 2010

Re: k102419

Trade Name: GSP Neonatal IRT kit (3306-001U) Regulation Number: 21 CFR §862.1725 Regulation Name: Trypsin Test System Regulatory Class: Class I exempt, exceeds the limitation to exemption in 862.9(c)(2) Product Codes: JNO Dated: November 24, 2010 Received: November 26, 2010

Dear Ms. 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 Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. 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 number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Signature

Courtney C. 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: GSP® Neonatal IRT Kit (3306-001U)

Indications for Use:

The GSP Neonatal IIXT kit is intended for the quantitative determination of human immunoreactive trypsin(ogen) in blood specimens dried on filter paper as an aid in screening newborns for Cystic Fibrosis using the GSP® instrument.

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)

Signature

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

510(k) k102419

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