(22 days)
Not Found
No
The description details a standard immunoassay kit and automated system, with no mention of AI or ML components in the device description, intended use, or performance studies.
No.
The device is used for the quantitative determination of 17 a- OH-progesterone in blood to aid in screening newborns for congenital adrenal hyperplasia (CAH), which is a diagnostic purpose, not a therapeutic one.
Yes
The device aids in screening newborns for congenital adrenal hyperplasia (CAH) by quantitatively determining 17 a-OH-progesterone in blood specimens, 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. It is not solely software.
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." This involves testing a sample taken from the body (blood) in vitro (outside the body).
- Device Description: The description details a "solid phase, time-resolved fluoroimmunoassay," which is a laboratory test method performed on biological samples.
- Sample Type: It uses "blood specimens dried on filter paper."
- Purpose: The purpose is to "aid in screening newborns for congenital adrenal hyperplasia (CAH)," which is a diagnostic purpose.
All these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 "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 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 kit |
| Common Name: | Fluoroimmunoassay, 17-hydroxyprogesterone |
| Classification: | Radioimmunoassay, 17-hydroxyprogesterone
Class 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.
1
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.
2
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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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
4
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