(381 days)
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.
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. Standards, 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 spots on the filter paper discs. The complete assay requires only one incubation step. Enhancement Solution dissociates europium ions from the labelled antibody into solution where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is the measured. The fluorescence of each sample is proportional to the concentration of IRT in the sample.
This document describes the AutoDELFIA Neonatal IRT L kit, an in vitro diagnostic device used for screening newborns for cystic fibrosis by quantitatively determining immunoreactive trypsin(ogen) (IRT) in dried blood specimens. The submission seeks to demonstrate substantial equivalence to a previously cleared device, the AutoDELFIA Neonatal IRT kit (K003668).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison of the new device (AutoDELFIA Neonatal IRT L kit, B022-112) with the predicate device (AutoDELFIA Neonatal IRT kit, B005-112). The goal is to show equivalent analytical performance characteristics.
| Acceptance Criterion (Implicitly based on Predicate Device Performance) | AutoDELFIA Neonatal IRT L kit Performance (B022-112) |
|---|---|
| Precision (Total variation) | CV% 9.5 - 11.0 |
| Limit of blank | 0.18 ng/mL (95th %tile) |
| Linearity | Linear range 13 - 370 ng/mL |
| Hook effect | No effect found up to IRT conc. 40,000 ng/mL |
| IRT distribution in newborns (Mean) | 22 ng/mL blood |
| IRT distribution in newborns (Median) | 18 ng/mL blood |
| IRT distribution in newborns (90th %tile) | 38 ng/mL blood |
| IRT distribution in newborns (95th %tile) | 47 ng/mL blood |
| IRT distribution in newborns (99th %tile) | 68 ng/mL blood |
Note: The text explicitly states "The analytical performance characteristics of the two kits are equivalent" implying that the performance of the new device matching or being comparably close to the predicate device serves as the acceptance criteria. For the IRT distribution, the differences are noted, suggesting that while not identical, they are considered within acceptable equivalence for substantial equivalence.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for the test set for the studies on precision, limit of blank, linearity, hook effect, or IRT distribution.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The studies described are analytical performance studies of an IVD kit, not studies requiring expert interpretation of results for ground truth. The "ground truth" for these tests would typically be defined by reference methods or established statistical analysis of the assay's performance characteristics.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple readers or experts assess cases. This document describes analytical performance studies of a diagnostic assay kit. Therefore, an adjudication method is not applicable and not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes the analytical validation of an in vitro diagnostic kit, not a study involving human readers interpreting results with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an automated immunoassay system (AutoDELFIA® automatic immunoassay system) that performs quantitative measurements. The performance data presented (precision, limit of blank, linearity, hook effect, IRT distribution) are standalone performance metrics of the assay kit itself, without human interpretation as part of the primary measurement. Human intervention would be for laboratory procedures and interpretation of the quantitative result against clinical cut-offs, but the device performance itself is standalone in terms of generating the IRT concentration.
7. The Type of Ground Truth Used
For the analytical performance characteristics:
- Precision: Established by repeated measurements.
- Limit of blank: Determined statistically from blank sample readings.
- Linearity: Assessed by analyzing samples of known, serially diluted concentrations.
- Hook effect: Investigated using samples with very high IRT concentrations.
- IRT distribution in newborns: This likely represents observed data from a population of newborns, which serves as the "ground truth" for reflecting the typical range of IRT in the target population. However, the exact method for establishing this, beyond sample analysis, is not detailed.
In essence, the "ground truth" for these studies is derived from analytical measurements and statistical analysis against reference materials or established methods, rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
The document describes the validation of an IVD kit, not an AI/ML algorithm that typically has a "training set." Therefore, the concept of a "training set sample size" as commonly understood in AI/ML is not applicable to this submission. The kit is based on established fluoroimmunometric assay principles and monoclonal antibodies.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" in the AI/ML context is not applicable. The assay's performance is established through calibration and validation studies using known standards and samples, similar to how analytical methods are developed and validated in general.
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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
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 OyMustionkatu 620750 Turku, Finland |
|---|---|
| Telephone: | +358-2-2678 111 |
| Fax: | +358-2-2678 357 |
| Contact Person: | Raija KoskivaaraRA Managerraija.koskivaara@perkinelmer.com |
| Date of Summary Prepared: | March 27, 2008 |
| Device Name: | AutoDELFIA Neonatal IRT L kit |
| Classification Name: | Chloride test system(21 CFR § 862.1170 / Product Code CGZ)Trypsin test system(21 CFR § 862.1725 / Product Code JNO) |
| Predicate Device: | AutoDELFIA Neonatal IRT kit510(k) Number: K003668 |
| Device Description: | The AutoDELFIA Neonatal IRT assay is a solid phase, two-sitefluoroimmunometric assay based on the direct sandwich technique in whichtwo monoclonal antibodies (derived from mice) are directed against twoseparate antigenic determinants on the IRT molecule. Standards, controls andtest specimens containing IRT are reacted simultaneously with immobilizedmonoclonal antibodies directed against a specific antigenic site on the IRTmolecule and europium -labeled monoclonal antibodies (directed against adifferent antigenic site) in assay buffer. The assay buffer elutes IRT from thedried blood spots on the filter paper discs. The complete assay requires onlyone incubation step.Enhancement Solution dissociates europium ions from the labelled antibodyinto solution where they form highly fluorescent chelates with components ofthe Enhancement Solution. The fluorescence in each well is the measured.The fluorescence of each sample is proportional to the concentration of IRT inthe 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 kitB005-112 (predicate device) | AutoDELFIA Neonatal IRT Lkit B022-112 | |
|---|---|---|
| Intended use | Quantitative determination of IRT inblood specimens dried on filter paperas an aid in screening newborns forcystic fibrosis | Same |
| Assay principle | Time-resolved fluoroimmunoassay | Same |
| Assay Procedure | Standards and Controls on filter paperare punched into wells | Liquid Standards and Controls aredispensed into wells. Extra flush toavoid a carry over effect |
| Antibodies / Cross reactivity | Monoclonal antibodies derived frommice | Same |
| Standards | 6 levels (Approx. values 0, 25, 50, 100,250 and 500 ng/mL) | Same |
| Controls | 3 levels (Approx. values 40, 70, 120ng/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 IRTconc. 40.000 ng/ mL | Same |
| IRT distribution in newborns | Mean: 27 ng/mL bloodMedian: 23 ng/mL blood90^th %tile: 42 ng/mL blood94^th %tile 50 ng/mL blood95^th %tile 52 ng/mL blood96^th %tile 55 ng/mL blood | Mean: 22 ng/mL bloodMedian: 18 ng/mL blood90^th %tile: 38 ng/mL blood95^th %tile47 ng/mL blood99^th %tile68 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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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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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
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)
Jivision Sign-Off
Office of In Vito Diagnostic Device Ivaluation and Safe
KD 70889
§ 862.1170 Chloride test system.
(a)
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.(b)
Classification. Class II.