(84 days)
Not Found
No
The description details a standard immunoassay technique based on competitive binding and fluorescence measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is intended for the quantitative determination of 17-OH-progesterone in blood specimens to aid in screening newborns for congenital adrenal hyperplasia (CAH), which is a diagnostic purpose, not a therapeutic one.
Yes
The intended use statement explicitly states that the kit is an "aid in screening newborns for congenital adrenal hyperplasia (CAH)," which is a diagnostic purpose.
No
The device description clearly outlines a physical immunoassay kit with reagents, antibodies, and a solid phase, which are hardware components. The device relies on a physical chemical reaction and subsequent fluorescence measurement, not solely on software processing.
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 17 a - 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 body (blood) in vitro (outside the body) to provide information about a medical condition (CAH).
- Device Description: The description details a "solid phase, time-resolved fluoroimmunoassay" which is a laboratory test method performed on a biological sample.
- Anatomical Site: The sample is "Blood specimens dried on filter paper," which is a biological specimen.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AutoDELFIA Neonatal 17α-OH-progesterone L kit is intended for the quantitative determination of 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-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.
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
Not Found
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 design control validation of the modified AutoDELFIA Neonatal 17α-OH-progesterone L kit has been done, and the performance of the modified kit is equivalent to the performance of the original AutoDELFIA Neonatal17a-OH-progesterone kit.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AutoDELFIA® Neonatal 17 α-OH-progesterone kit, K042425
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.
0
Image /page/0/Picture/0 description: The image shows the logo for PerkinElmer. The logo consists of a stylized "P" with a triangle shape above it, followed by the name "PerkinElmer" in a sans-serif font. Below the name, the word "precisely" is written in a smaller, italicized font.
JUL 1 1 2005
- PerkinElmer Life and Analytical Sciences Wallac Ov PO Box 10 FIN-20101 Turku Finlar Phone: +358 - 1012 - 267 8111
the //www nerkinelmer com
510(k) SUMMARY (as required by 21 CFR 807.92)
The assigned 510(k) number is: K050960
| Submitted by: | Gunnel Laaksonen
Regulatory Affairs Manager
Wallac Oy
Mustionkatu 6, 20750 Turku
P.O. Box 10, 20101 Turku
Finland |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | AutoDELFIA® Neonatal 17 α-OH-progesterone L kit |
| Common Name: | Fluoroimmunoassay, 17-hydroxyprogesterone |
| Classification: | Radioimmunoassay, 17-hydroxyprogesterone
Class I per 21 CFR § 862.1395 |
| Product Code: | JLX |
| Predicate Device: | AutoDELFIA® Neonatal 17 α-OH-progesterone kit, K042425 |
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.
1
Image /page/1/Picture/0 description: The image shows the PerkinElmer logo. The logo consists of a stylized "P" with a triangle pointing to the right, followed by the word "PerkinElmer" in a bold, sans-serif font. Below the company name is the word "precisely." in a smaller font.
Indications for Use:
The AutoDELFIA Neonatal 17α-OH-progesterone L kit is intended for the quantitative determination of 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.
Substantial Equivalence:
The modified B006-112 AutoDELFIA Neonatal 17α-ΟΗ-progesterone L kit has the same Intended Use and Indications for Use as the original B015-112 AutoDELFIA Neonatal 17α-ΟΗ-progesterone kit (k 042425 ), and is based on the same assay principle.
The design control validation of the modified AutoDELFIA Neonatal 17α-OH-progesterone L kit has been done, and the performance of the modified kit is equivalent to the performance of the original AutoDELFIA Neonatal17a-OH-progesterone kit.
In summary, the modified B006-112 AutoDELFIA Neonatal 17α-OHprogesterone L kit described in this Special 510 (k) submission has been shown to be substantially equivalent to the original B015-112 AutoDELFIA Neonatal 17a-OH-progesterone kit.
2
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 features a stylized eagle with three lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
JUL 1 1 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Gunnel Laaksonen Regulatory Affairs Manager PerkinElmer Life and Analytical Sciences Wallac Oy Mustionkatu 6, 20750 P.O. Box 10 FIN-20101 Turku Finland
$
K050960 Re: R050700
Trade/Device Name: AutoDELFIA® Neonatal 17 α-OH- progesterone L kit Regulation Number: 21 CFR 862.1395 Regulation Name: 17- Hydroxyprogesterone test system Regulatory Class: Class I Product Code: JLX Dated: June 15, 2005 Received: July 5, 2005
Dear Ms. Laaksonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10) use stated in the encrobate) to regard) the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recation in acceraaned with has aremarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appli and Costlience Act (Act) that do not require subject to the general controls provisions of the Act. The f ou may, mercrore, market the device, seeject of the general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is Classified (See above) into . Existing major regulations affecting your device it may oe subject to such additional controllar controllations (CFR), Parts 800 to 895. In addition, FDA can be louid in 11the 21, Code of I eceral suggest on the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a substance on the other requirements of the Act the that FDA has made a decemmanon that your istered by other Federal agencies. You must list or any Federal statutes and regulations damandors, but not limited to: registration and listing (21)
comply with all the Act's requirements, including, but not studies and ti comply with an the Act 3 requirements, the and 809); and good manufacturing practice CFK Patt 807), labeling (21 OF N Fitte systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to ough finding of substantial equivalence of your device to a legally prematics notification " " 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, If you desire opention and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the Vitro Duelloode DeMisbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may other general michiational 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/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
.
510(k) Number :
Device Name:
AutoDELFIA® Neonatal 17 a-OH-progesterone L 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
-Counter Use
(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)
Alberto Sa A
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510 K050960