(283 days)
1235
No
The device description details a standard immunoassay based on competitive binding and fluorescence measurement. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis is based on a direct measurement of 17-OHP concentration, not an interpretation or prediction using AI/ML algorithms.
No
This device is an in vitro diagnostic (IVD) kit used for screening, not for treatment or therapy. It measures a biomarker to aid in the diagnosis of a condition.
Yes
Explanation: The device is intended for the "quantitative determination of human 17a-OH-progesterone in blood specimens... as an aid in screening newborns for congenital adrenal hyperplasia (CAH)". This aligns with the definition of a diagnostic device, as it provides information used to aid in the diagnosis or screening of a medical condition.
No
The device description clearly outlines a solid phase, time-resolved fluoroimmunoassay kit involving reagents, antibodies, and a measurement system (1235 AutoDELFIA® automatic immunoassay system). This is a hardware-based diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of human 17a-OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH)". This involves testing a sample taken from the human body (blood) in vitro (outside the body) to provide information about a physiological state (screening for CAH).
- Device Description: The description details a "solid phase, time-resolved fluoroimmunoassay" which is a laboratory method used to measure substances in biological samples. This is a typical characteristic of an IVD.
- Sample Type: The device uses "blood specimens dried on filter paper," which are biological samples.
- Purpose: The purpose is to "aid in screening newborns for congenital adrenal hyperplasia (CAH)," which is a diagnostic purpose.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AutoDELFIA® Neonatal 17a-OH-progesterone kit is intended for the quantitative determination of human 17a-OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA® automatic immunoassay system.
Product codes
JLX
Device Description
The AutoDELFIA Neonatal 17α-OH-progesterone (17-OHP) assay is a solid phase, time-resolved fluoroimmunoassay based on the competitive reaction between europium-labeled 17-OHP and sample 17-OHP for a limited amount of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibody-bound and free antigen. Enhancement Solution dissociates europium ions from the labeled antigen 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 inversely proportional to the concentration of 17-OHP in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Newborns
Intended User / Care Setting
Adequately trained laboratory personnel in laboratories performing newborn screening
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed kit and the predicate device were compared in two newborn screening laboratories using retrospective specimens and excess samples. A number of known CAH cases were included.
Study 1: 17 confirmed CAH case samples were available.
Study 2: 13 confirmed CAH case samples were available (in the >= 2250g birth weight category only).
Key Results:
The tables in the summary (Table 2 - Table 13) show screening results and true diagnosis for different weight categories and percentiles (90th and 95th) comparing the Proposed Device (New kit B024) and Predicate Device (Old kit B015). The results are categorized based on whether subjects were diagnosed (CAH) or not diagnosed (No diagnosed CAH).
One false negative result was observed in Study 2 in the >= 2250g weight category, 95th percentile, for the new kit when using percentiles higher than the 90th percentile as the assay's cut-off.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1395 17-Hydroxyprogesterone test system.
(a)
Identification. A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.(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.
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Image /page/0/Picture/0 description: The image shows the logo for PerkinElmer. The logo consists of a stylized graphic element above the company name. The graphic element is a combination of a thick vertical bar and a triangle pointing to the right. Below the company name, the tagline "For the Better" is written in a smaller, italicized font.
APK 1 6 2009
.
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: _______________________________________________________________________________________________________________________________________________
| Submitter: | Wallac Oy
Mustionkatu 6
20750 Turku, Finland |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | +358 2 2678111 |
| Fax: | +358 2 2678357 |
| Contact Person: | Katriina Suonpää
Regulatory Affairs Manager
katriina.suonpaa@perkinelmer.com |
| Date of Summary Prepared: | April 07, 2009 |
| Device Name: | AutoDELFIA® Neonatal 17α-OH-progesterone kit |
| Classification Name: | Radioimmunoassay, 17-Hydroxyprogesterone
Class I per 21 CFR § 862.1395 |
| Product Code: | JLX |
| Predicate Device: | AutoDELFIA® Neonatal 17α-OH-progesterone kit,
510(k) Number K042425 |
| Device Description: | The AutoDELFIA Neonatal 17α-OH-progesterone
(17-OHP) assay is a solid phase, time-resolved
fluoroimmunoassay based on the competitive reaction
between europium-labeled 17-OHP and sample 17-OHP
for a limited amount of binding sites on 17-OHP specific
polyclonal antibodies (derived from rabbit). Danazol
facilitates the release of 17-OHP from the binding
proteins. A second antibody, directed against rabbit IgG,
is coated to the solid phase, giving convenient separation
of the antibody-bound and free antigen. |
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Image /page/1/Picture/0 description: The image shows the logo for PerkinElmer. The logo consists of a stylized graphic element above the company name. The graphic element is composed of a thick vertical line and a triangle pointing to the right. Below the company name, the tagline "For the Better" is written in a smaller, italicized font.
Enhancement Solution dissociates europium ions from the labeled antigen 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 inversely proportional to the concentration of 17-OHP in the sample.
Intended Use: The AutoDELFIA Neonatal 17a-OH-progesterone kit is intended for the quantitative determination of human 17a-OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA® automatic immunoassay system.
The AutoDELFIA Neonatal 17α-OH-progesterone kit Substantial Equivalence: (B024) is substantially equivalent to our currently marketed AutoDELFIA Neonatal 17x-OH-progesterone kit (B015) (K042425). The primary difference is a new antiserum in B024. The new antiserum has less crossreactivity with the physiologically important steroids in neonates, making it more specific for measuring 17a-OHprogesterone. There are the following similarities and differences between the two kits:
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·
Table 1. Characteristics of the two kits.
| Characteristic | Proposed Device | Predicate Device |
|---|---|---|
| AutoDELFIA Neonatal | ||
| 17α-OH-progesterone kit | ||
| B024 | AutoDELFIA Neonatal | |
| 17α-OH-progesterone kit | ||
| B015 | ||
| Similarities | ||
| Intended User | Adequately trained laboratory personnel in laboratories performing newborn screening | Adequately trained laboratory personnel in laboratories performing newborn screening |
| Intended Use | Quantitative determination of 17α-OH-progesterone in blood specimens dried on filter paper | Quantitative determination of 17α-OH-progesterone in blood specimens dried on filter paper |
| Indication for Use | An aid in screening newborns for congenital adrenal hyperplasia | An aid in screening newborns for congenital adrenal hyperplasia |
| Chemical Principle | Competitive reaction between europium labeled 17-OHP and sample 17-OHP for a limited number of binding sites on 17-OHP specific polyclonal antibodies derived from rabbit | Competitive reaction between europium labeled 17-OHP and sample 17-OHP for a limited number of binding sites on 17-OHP specific polyclonal antibodies derived from rabbit |
| Assay Principle | Time-resolved fluoroimmunoassay | Time-resolved fluoroimmunoassay |
| Instrument | 1235 AutoDELFIA automatic immunoassay system | 1235 AutoDELFIA automatic immunoassay system |
| Detection principle | Time-resolved fluorescence | Time-resolved fluorescence |
| Specimen | Filter paper disks with a diameter of approximately 3.2 mm (1/8 inch) | Filter paper disks with a diameter of approximately 3.2 mm (1/8 inch) |
| Calibrator and | ||
| Control Matrix | Human blood with a hematocrit of 50-55% and spotted onto filter paper cassettes (Whatman Grade 903) | Human blood with a hematocrit of 50-55% and spotted onto filter paper cassettes (Whatman Grade 903) |
| Calibration | Calibrated using gravimetric methods | Calibrated using gravimetric methods |
| Controls | 3 levels (approx. values 17, 45 and 100 ng/mL serum) | 3 levels (approx. values 17, 45 and 100 ng/mL serum) |
| Assay Buffer | 17-OHP Assay Buffer, ready for use | 17-OHP Assay Buffer, ready for use |
| Coated Plates | Anti-rabbit IgG Microtitration Strips, | |
| 8 x 12 wells coated with anti-rabbit | ||
| IgG (raised in goat) | Anti-rabbit IgG Microtitration Strips, | |
| 8 x 12 wells coated with anti-rabbit | ||
| IgG (raised in goat) | ||
| Characteristic, | ||
| continued | Proposed Device | |
| AutoDELFIA Neonatal | ||
| 17α-OH-progesterone kit | ||
| B024 | Predicate Device | |
| AutoDELFIA Neonatal | ||
| 17α-OH-progesterone kit | ||
| B015 | ||
| Differences | ||
| Antibodies | Rabbit polyclonal antibodies | Different rabbit polyclonal antibodies |
| Antibody | ||
| Cross-Reactions | ||
| in the Assay | 17α-OH pregnenolone sulfate 0.78 % | |
| 11-Deoxycortisol 0.62 % | ||
| 17α-OH pregnenolone 0.83 % | ||
| Progesterone 0.37 % | 17α-OH pregnenolone sulfate 2.0 % | |
| 11-Deoxycortisol 1.82 % | ||
| 17α-OH pregnenolone 1.20 % | ||
| Progesterone 0.47 % | ||
| Tracer | 17-OHP-Eu tracer stock solution, approximate concentration of 40 nmol/L, lyophilized | 17-OHP-Eu tracer stock solution, approximate concentration of 250 nmol/L, lyophilized |
| Calibrators | 6 levels | |
| (approx. values 0, 4, 10, 25, 75, and 220 ng/mL serum) | 6 levels | |
| (approx. values 0, 10, 25, 50, 100 and 250 ng/mL serum) | ||
| Analytical Sensitivity / | ||
| Limit of Blank, | ||
| Limit of Detection, | ||
| Limit of Quantitation | Limit of Blank | |
| 0.37 ng/mL serum | ||
| Limit of Detection | ||
| 0.84 ng/mL serum | ||
| Limit of Quantitation | ||
| 1.4 ng/mL serum | Analytical Sensitivity | |
| (Limit of Blank) 1.3 ng/mL serum | ||
| Precision (Total | ||
| Variation using a full | ||
| calibration curve on | ||
| each plate) | 2.12 ng/mL serum CV% 13.0 | |
| 4.69 ng/mL serum CV% 9.8 | ||
| 7.52 ng/mL serum CV% 14.8 | ||
| 27.0 ng/mL serum CV% 8.3 | ||
| 54.4 ng/mL serum CV% 9.2 | ||
| 109 ng/mL serum CV% 10.8 | ||
| 182 ng/mL serum CV% 9.1 | 25.9 ng/mL serum CV% 13.2 | |
| 53.0 ng/mL serum CV% 10.8 | ||
| 114 ng/mL serum CV% 10.9 | ||
| Precision (Total | ||
| Variation using one | ||
| calibration curve for | ||
| every batch of 4 plates) | 2.25 ng/mL serum CV% 14.0 | |
| 4.89 ng/mL serum CV% 12.0 | ||
| 7.79 ng/mL serum CV% 15.8 | ||
| 27.7 ng/mL serum CV% 9.7 | ||
| 55.7 ng/mL serum CV% 10.5 | ||
| 113 ng/mL serum CV% 12.7 | ||
| 188 ng/mL serum CV% 11.3 | 25.8 ng/mL serum CV% 14.0 | |
| 52.9 ng/mL serum CV% 12.4 | ||
| 115 ng/mL serum CV% 11.8 | ||
| Median Values in | ||
| Newborn Screening | ||
| (Study 1) | 2250 g 6.7 ng/mL serum | 2250 g 14.1 ng/mL serum |
| Median Values in | ||
| Newborn Screening | ||
| (Study 2) | 2250 g 7.1 ng/mL serum | 2250 g 13.7 ng/mL serum |
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4
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Screening Efficacy:
The proposed kit and the predicate device were compared in two newborn screening laboratories using retrospective specimens and excess samples. A number of known CAH cases were included. The results categorizing the number of evaluation samples according to screening outcome are shown in Tables 2-7 (Study 1) and in Tables 8-13 (Study 2).
Study 1, Tables 2 - 7:
In total, 17 confirmed CAH case samples were available for the study. All of them were retrospective samples.
Table 2. Screening results and true diagnosis in the