(22 days)
This kit is intended for the quantitative determination of 17 a- 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-ΟΗ-progesterone (17-ΟΗΡ) assay is a solid phase, time-resolved fluoroimmunoassay based on the competition 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). 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 antibodybound and free antigen. Enhancement Solution dissociates europium ions from the labeled antiserum 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 quantity of 17-OHP in the sample.
The provided text does not contain detailed acceptance criteria or a specific study that outlines how the device demonstrably meets those criteria. The document is a 510(k) summary for the "AutoDELFIA® Neonatal 17 α-OH-progesterone kit," which focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.
However, based on the information provided, we can infer some aspects related to device performance and study design:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria. Instead, it relies on the concept of "substantial equivalence" to a predicate device. The performance of the modified kit was found to be "equivalent" and "suitable for its intended use."
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Equivalence to predicate device (K912026 / K935047) in intended use and assay principle. | Performance of the modified kit was found to be equivalent to the predicate AutoDELFIA Neonatal 17a-OH-progesterone kit. |
| Suitability for intended use (screening newborns for CAH). | Performance was found to be suitable for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for the performance evaluation. It mentions "in-house studies and by studies in neonatal screening laboratories."
- Data Provenance: The studies were conducted "in-house" and "in neonatal screening laboratories." The country of origin for the submitting company (Wallac Oy) is Finland, suggesting that some or all of the studies might have taken place in Finland or other European neonatal screening centers. The document does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The device is for quantitative determination and screening, which typically relies on established medical thresholds and clinical diagnoses rather than expert consensus on individual test results for ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study mentioned: The device is an immunoassay kit for quantitative determination, not an AI-powered diagnostic imaging or interpretation tool that would involve human readers. Therefore, an MRMC study and analysis of human reader improvement with AI would not be applicable or relevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implicitly a standalone device: The AutoDELFIA system is an automated immunoassay system. The "kit" refers to the reagents and consumables used with this system to perform the quantitative determination of 17α-OH-progesterone. As such, the performance of the kit, when used with the AutoDELFIA system, is inherently "standalone" in generating a quantitative result. There isn't a human-in-the-loop interpreting a visual output from the algorithm in the way one might with an imaging AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state how ground truth was established for the performance studies. For a screening test like this, ground truth for CAH would typically be established through:
- Clinical diagnosis: Confirmation of CAH through subsequent diagnostic tests, genetic testing, and clinical assessment.
- Pathology/Biochemical confirmation: Measurement of other steroid hormones, genetic analysis, or enzyme activity tests that definitively diagnose CAH.
Given the nature of the device as a quantitative assay for a biomarker, the comparison would likely be against established clinical diagnostic criteria for CAH.
8. The Sample Size for the Training Set
This information is not provided. As an immunoassay kit, it's unlikely to have a "training set" in the machine learning sense. The "training" in developing such a kit would involve optimizing reagent concentrations, reaction conditions, and calibration procedures, which is a different paradigm than data-driven AI model training.
9. How the Ground Truth for the Training Set was Established
Not applicable as it's not an AI model requiring a training set with explicitly established ground truth in the AI sense. Development of the assay would involve various analytical validation studies.
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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, with the word "precisely." written in a smaller font below the name. The logo is black and white.
PerkinElmer Life and Analytical Sciences Wallac Ov P.O. Box 10 EIN 20101 Turku F
510(k) SUMMARY
SEP 3 0 2004
(as required by 21 CFR 807.92)
The assigned 510(k) number is:
| Submitted by: | Gunnel LaaksonenRegulatory Affairs ManagerWallac OyMustionkatu 6, 20750 TurkuP.O. Box 10, 20101 TurkuFinland |
|---|---|
| Device Name: | AutoDELFIA® Neonatal 17 α-OH-progesterone kit |
| Common Name: | Fluoroimmunoassay, 17-hydroxyprogesterone |
| Classification: | Radioimmunoassay, 17-hydroxyprogesteroneClass I per 21 CFR § 862.1395 |
JLX Product Code:
- DELFIA® / AutoDELFIA® Neonatal 17 a-OH-progesterone kit, K912026/ Predicate Device: K935047
Device Description:
The AutoDELFIA Neonatal 17α-ΟΗ-progesterone (17-ΟΗΡ) assay is a solid phase, time-resolved fluoroimmunoassay based on the competition 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). 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 antibodybound and free antigen.
Enhancement Solution dissociates europium ions from the labeled antiserum 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 quantity of 17-OHP in the sample.
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Image /page/1/Picture/0 description: The image shows the logo for PerkinElmer. The logo consists of the name "PerkinElmer" in a bold, sans-serif font, with the word "precisely." underneath in a smaller font. Above the name is a stylized graphic element that resembles a thick, angled line with a curved shape cut out of the right side.
Indications for Use:
The AutoDELFIA Neonatal 17α-ΟΗ-progesterone kit is intended for the quantitative determination of 17α-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.
Sustantial Equivalence:
The modified AutoDELFIA Neonatal 17α-0H-progesterone kit has the same intended use and is based on the same assay principle as the predicate DELFIA / AutoDELFIA Neonatal17α-OH-progesterone kits (K912026 / K935047).
The performance of the modified AutoDELFIA Neonatal 17a-OHprogesterone kit was tested both by carrying out in-house studies and by studies in neonatal screening laboratories. The performance of the modified kit was found to be equivalent with the predicate AutoDELFIA Neonatal 17a-OH-progesterone kit and suitable for its intended use.
In summary, the AutoDELFIA Neonatal 17α-ΟΗ-progesterone kit described in this submission is, in our opinion, substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES USA
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Gunnel Laaksonen Manager of Regulatory Affairs Wallac Oy P.O. Box 10 FIN-20101 Turku, Finland
SEP 3 0 2004
Re: K042425
Trade/Device Name: AutoDELFIA® Neonatal 17 a- OH- progesterone kit Regulation Number: 21 CFR 862.1395 Regulation Name: 17-Hydroxyprogesterone test system Regulatory Class: Class I Product Code: JLX Dated: August 31, 2004 Received: September 8, 2004
Dear Mr. Laaksonen:
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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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) remarket 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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, US. DVM.
Jean M. Cooper, MS, 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 :
Device Name:
AutoDELFIA® Neonatal 17 a-OH-progesterone kit
Indications For Use:
Indications For Use: This kit is intended for the quantitative determination of 17 a- 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.
Prescription Use _
Over-The-Counter Use AND/OR
(21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Allektatz
Division Sign-Off
Office of In Vitro Diagnostic e Evaluation and
§ 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.