(113 days)
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 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. 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.
The provided text describes the GSP Neonatal IRT kit, a device for screening newborns for cystic fibrosis. It compares the new device to a predicate device (AutoDELFIA Neonatal IRT kit) and presents information on its performance characteristics.
Here’s a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device K0003668) | Reported Device Performance (GSP Neonatal IRT kit) |
|---|---|---|
| Intended Use / Indications for Use | 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. | Quantitative determination of IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the GSP® instrument. |
| Instrument | 1235 AutoDELFIA Instrument | GSP Instrument |
| Dissociation solution | Enhancement Solution | DELFIA Inducer |
| Antibody Cross-Reactions | ||
| α2-macroglobulin | < 4 ng/ml blood | 0.000% |
| α1-antitrypsin | < 4 ng/ml blood | 0.000% |
| Phospholipase A2 | < 4 ng/ml blood | 0.014% |
| Chymotrypsin | < 4 ng/ml blood | 0.959% |
| Human IgG | < 4 ng/ml blood | 0.000% |
| Pepsinogen | < 4 ng/ml blood (Uro)Pepsinogen | -0.056% |
| Complement Factor I | NA | 0.000% |
| Measuring Range | 4 (as defined by LoB) to 500 (as defined by upper calibrator) ng/mL blood | 9 to 500 ng/mL blood |
| Tracer | Anti-IRT-Eu tracer stock solution, approximate concentration of ~50 µg/ml mouse monoclonal | Anti-IRT-Eu tracer stock solution, approximate concentration of ~40 µg/ml mouse monoclonal |
| Analytical Sensitivity / Limit of Blank | < 4 ng/mL blood | Limit of Blank: 0.76 ng/mL blood |
| Limit of Detection | Not explicitly stated for predicate; implied by LoB | 2.2 ng/mL blood |
| Limit of Quantitation | Not explicitly stated for predicate; implied by LoB | 2.2 ng/mL blood |
| Precision (Total Variation) | 42.6 ng/mL blood CV% 9.3; 98.8 ng/mL blood CV% 10.0; 266 ng/mL blood CV% 9.6 | 10.9 ng/mL blood CV% 7.3; 22.2 ng/mL blood CV% 7.2; 28.5 ng/mL blood CV% 7.0; 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 CV% 7.5 |
Study Proving Device Meets Acceptance Criteria:
The document describes a substantial equivalence claim, not a separate clinical study with independent acceptance criteria beyond demonstrating equivalence to the predicate device. The "study" here is the comparison and characterization of the new device's performance against the established predicate device (AutoDELFIA Neonatal IRT kit, K0003668). The acceptance criteria are largely implicitly defined by the performance characteristics of the predicate device, where the new device is shown to have similar or improved performance in analytical parameters.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state a sample size for a test set in the context of a clinical study. The performance characteristics reported (e.g., precision, analytical sensitivity, measuring range) are typically derived from analytical verification and validation studies in a laboratory setting.
- Sample Size: Not explicitly stated for a "test set" in a clinical context. The precision data lists various IRT concentrations tested, and each CV% (Coefficient of Variation) would have been derived from replicate measurements.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies generating these performance characteristics were retrospective or prospective. It describes the device's analytical performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. This is an in-vitro diagnostic device for measuring a biomarker (IRT). The "ground truth" for its performance is based on analytical measurements and comparison to a known standard, not on expert clinical evaluation or interpretation of images.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., images) by multiple human readers, not in the analytical validation of an in-vitro diagnostic assay measuring a biomarker.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
N/A. An MRMC study is not applicable to the analytical performance evaluation of this type of in-vitro diagnostic device. This device measures a quantitative biomarker and does not involve human interpretation of cases or "readers" in the traditional sense, nor does it aim to improve human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The device itself is a "standalone" assay in the sense that it quantifies IRT levels directly from a blood spot sample using an instrument. There is no human interpretation of an algorithm output, but rather a direct measurement that aids in screening. The GSP® instrument performs the assay automatically.
7. The Type of Ground Truth Used
The ground truth for the device's performance (especially for parameters like measuring range, sensitivity, and precision) would be established by:
- Reference materials/calibrators: Samples with known concentrations of IRT (calibrated using gravimetric methods, as mentioned).
- Established analytical methods: Comparison to recognized analytical techniques for IRT measurement.
This is not "expert consensus, pathology, or outcomes data" in the clinical sense, but rather a robust analytical validation against known standards.
8. The Sample Size for the Training Set
N/A. This document pertains to an in-vitro diagnostic kit for measuring a biomarker, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The device's performance is based on its chemical and immunological assay design.
9. How the Ground Truth for the Training Set was Established
N/A. As stated above, this is not an AI/ML device that uses a "training set."
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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: 781-663-5872 Fax: 781-663-5983 Kay A. Taylor Secondary: Tel: 317-418-1735 Fax: 317-536-3064 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.
l
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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(New Device) | AutoDELFIA Neonatal IRT kit(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.DELFIA Inducer dissociates europium ions from the | Same | |
| Characteristic | GSP NeonatalIRT kit(New Device) | AutoDELFIA NeonatalIRT kit(Predicate Device) | |
| fluorescent chelates withcomponents of the DELFIAInducer. The fluorescence ineach well is then measured.The fluorescence of eachsample is proportional to theconcentration of IRT in thesample. | |||
| Detection principle | Time-resolved fluorescence | Same | |
| Specimen | Dried blood on filter paperdisks with a diameter ofapproximately 3.2 mm (1/8inch) | Same | |
| Antibodies | Two different mousemonoclonal antibodies | Same | |
| Calibrator and Control Matrix | Human blood derivative witha hematocrit of 50-55% andspotted onto filter papercassettes (Whatman, no. 903) | Same | |
| (Washed RBCs in buffercontaining BSA and proteaseinhibitors) | (Washed RBCs in buffercontaining saccharose) | ||
| Calibration | Calibrated using gravimetricmethods | Same | |
| Controls | 3 levels (approx. values 30, 70and 110 ng/mL blood) | Same | |
| Assay buffer | IRT Assay Buffer, ready foruse | Same | |
| Containing blockers and BSAitem 1 | Containing BSA item 2 | ||
| Calibrators | 6 levels(approx. values 0, 25, 50, 100,250, 500 ng/mL blood) | Same | |
| Expected Values | The measurement of IRTfrom dried blood spots is usedas a means of identifying apopulation of newborns whoare at increased risk of havingCF and should be selected for2nd tier testing. Theidentification is based on theuse of a fixed cut-off value orpopulation percentile. The | Same | |
| Characteristic | GSP NeonatalIRT kit | AutoDELFIA NeonatalIRT kit | |
| (New Device) | (Predicate Device) | ||
| determined by each newbornscreening laboratory to meetthe desired sensitivity andspecificity of the screen andshould be evaluatedperiodically. | |||
| Coated Plates | Anti-IRT MicrotitrationStrips, 8 X 12 wells coatedwith antibodies directedagainst a specific site on theIRT molecule (mousemonoclonal) | Same | |
| Microtitration plate rawmaterial item 1. | Microtitration plate rawmaterial item 2 | ||
| Characteristic | GSP NeonatalIRT kit(New Device) | Differences | AutoDELFIA NeonatalIRT kit(Predicate Device) |
| Instrument | GSP Instrument | 1235 AutoDELFIA Instrument | |
| Dissociation solution | DELFIA Inducer | Enhancement Solution | |
| AntibodyCross-Reactionsin the Assay | α2-macroglobulin | 0.000% | α2-macroglobulin < 4 ng/mlblood |
| α1-antitrypsin | 0.000% | α1-antitrypsin < 4 ng/ml blood | |
| Phospholipase A2 | 0.014% | Phospholipase A2 < 4 ng/mlblood | |
| 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 (asdefined by upper calibrator)ng/mL blood | |
| Linearity Range: 9 to500 ng/mLblood | Linearity Range: No claims forlinearity in labeling. | ||
| Tracer | Anti-IRT-Eu tracer stocksolution, approximateconcentration of~40 µg/ml mouse monoclonal | Anti-IRT-Eu tracer stocksolution, approximateconcentration of~50 µg/ml mouse monoclonal |
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:
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| ready for use. | ready for use. | |
|---|---|---|
| Tracer antibody labeling witheuropium-chelate 1 | Tracer antibody labeling witheuropium-chelate 2 | |
| Contains mouse IgG as blocker. | ||
| Analytical Sensitivity / Limit ofBlank, | Limit of Blank0.76 ng/mL blood | Limit of Blank< 4 ng/mL blood |
| Limit of Detection | Limit of Detection2.2 ng/mL blood | |
| Limit of Quantitation | Limit of Quantitation2.2 ng/mL blood | |
| Precision (Total Variation usinga full calibration curve on eachplate) | 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 bloodCV% 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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 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
Page 1 of _1
§ 862.1725 Trypsin test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.