(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).
The DELFIA Neonatal 17α-OH-progesterone (17-OHP) 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 is a 510(k) summary for the DELFIA® Neonatal 17α-OH-progesterone kit. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or information about sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fully answer your request for a table of acceptance criteria and reported device performance or information about the study design elements you asked for. The document states:
"The performance of the modified DELFIA Neonatal 17α-OH-progesterone 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 DELFIA Neonatal 17α-OH-progesterone kit and suitable for its intended use."
This statement confirms that studies were done and the device met performance expectations by showing equivalence to a predicate device, but it lacks the quantitative details required to populate your requested table and answer your specific questions about the study methodology.
Without further information from the detailed submission to the FDA, I cannot provide the specifics you're looking for.
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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 with a triangle pointing to the right, followed by the text "PerkinElmer" in a bold, sans-serif font. Below the company name, the word "precisely." is written in a smaller, lighter font.
SEP 3 0 2004
erkin Elmer Life and Analytical Sciences
510(k) SUMMARY (as required by 21 CFR 807.92)
The assigned 510(k) number is:
| Submitted by: | Gunnel Laaksonen |
|---|---|
| Regulatory Affairs Manager | |
| Wallac Oy | |
| Mustionkatu 6, 20750 Turku | |
| P.O. Box 10, 20101 Turku | |
| Finland |
DELFIA® Neonatal 17 a-OH-progesterone kit Device Name:
Fluoroimmunoassay, 17-hydroxyprogesterone Common Name:
- Classification: Radioimmunoassay, 17-hydroxyprogesterone Class I per 21 CFR § 862.1395
Product Code: JLX
DELFIA® Neonatal 17 a-OH-progesterone kit, K912026 Predicate Device:
Device Description:
The DELFIA Neonatal 17α-OH-progesterone (17-OHP) 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 a stylized "P" shape formed by a vertical bar and a right-pointing triangle. Below the symbol is the text "PerkinElmer" in a bold, sans-serif font. Underneath "PerkinElmer" is the word "precisely." in a smaller, lighter font.
Indications for Use:
The DELFIA Neonatal 17α-OH-progesterone kit is intended for the The DEEF in Nooriation of 17a-OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH).
Sustantial Equivalence:
The modified DELFIA Neonatal 17α-OH-progesterone kit has the same intended use and is based on the same assay principle as the predicate DELFIA Neonatal 17α-OH-progesterone kit (K912026).
The performance of the modified DELFIA 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 DELFIA Neonatal 17α-OH-progesterone kit and suitable for its intended use.
In summary, the modified DELFIA Neonatal17a-OH-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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged around the circumference of the circle.
ood and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 3 0 2004
Mr. Gunnel Laaksonen Manager of Regulatory Affairs Wallac Oy P.O. Box 10 FIN-20101 Turku Finland
K042424 Re:
K042424
Trade/Device Name: DELFIA® 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 we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosury to 10g-20 the enactment date of the Medical Device Amendments, or to commerce proc to May 20, 1978, the excordance 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 I ou may, diereleve, mains of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 your device is classified (650 additional controls. Existing major regulations affecting your device it may oc subject it bach additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 can be found in Title 21, oncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oc advisou that I Driveran that your device complies with other requirements of the Act that I Dri has made a aowd regulations administered by other Federal agencies. You must or any it cacal statuted and regarments, 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) I mis letter will and hy July finding of substantial equivalence of your device to a legally promaticated 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,
Seain M. Cooper, U.S., 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 :
<04 2424
Device Name:
DELFIA® 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).
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Alberto Gutz
Division Sign-Off
Office of In Vitro Die Device Evaluation o
510(k) KD42424
§ 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.