(381 days)
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No
The description details a standard immunoassay technique based on chemical reactions and fluorescence measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic (IVD) immunoassay kit used to screen newborns for cystic fibrosis by measuring IRT levels, which aids in diagnosis rather than directly treating or preventing a disease.
Yes
The device aids in screening newborns for cystic fibrosis by quantitatively determining immunoreactive trypsin (ogen) in blood specimens, which is a diagnostic purpose.
No
The device description clearly outlines a solid phase, two-site fluoroimmunometric assay involving physical reagents (monoclonal antibodies, assay buffer, Enhancement Solution) and a physical system (1235 AutoDELFIA® automatic immunoassay system) to measure fluorescence. This is a hardware-based immunoassay system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's 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." This involves testing a sample taken from the body (blood) in vitro (outside the body) to provide information about a medical condition (cystic fibrosis screening).
- Device Description: The description details a "solid phase, two-site fluoroimmunometric assay" which is a laboratory test method performed on biological samples.
- Anatomical Site: The sample is "Blood specimens dried on filter paper," which is a biological specimen.
These characteristics align perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
CGZ, JNO
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Newborns
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- 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; Median: 18 ng/mL blood; 90th %tile: 38 ng/mL blood; 95th %tile: 47 ng/mL blood; 99th %tile: 68 ng/mL blood
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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 Oy
Mustionkatu 6
20750 Turku, Finland |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | +358-2-2678 111 |
| Fax: | +358-2-2678 357 |
| Contact Person: | Raija Koskivaara
RA Manager
raija.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 kit
510(k) Number: K003668 |
| Device Description: | 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. |
1
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:
2
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
B005-112 (predicate device) | AutoDELFIA Neonatal IRT L
kit B022-112 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Quantitative determination of IRT in
blood specimens dried on filter paper
as an aid in screening newborns for
cystic fibrosis | Same |
| Assay principle | Time-resolved fluoroimmunoassay | Same |
| Assay Procedure | Standards and Controls on filter paper
are punched into wells | Liquid Standards and Controls are
dispensed into wells. Extra flush to
avoid a carry over effect |
| Antibodies / Cross reactivity | Monoclonal antibodies derived from
mice | Same |
| Standards | 6 levels (Approx. values 0, 25, 50, 100,
250 and 500 ng/mL) | Same |
| Controls | 3 levels (Approx. values 40, 70, 120
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 |