(314 days)
Not Found
No
The 510(k) summary describes a standard chromatographic immunoassay for detecting hCG in urine. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies and key metrics are typical for this type of diagnostic test and do not indicate AI/ML involvement.
No
Explanation: This device is for the detection of pregnancy, which is a diagnostic purpose, not a therapeutic one. It does not treat or alleviate any medical condition.
Yes
Explanation: The device is described as a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the early detection of pregnancy. This process of detecting a specific substance (hCG) to determine a medical condition (pregnancy) is inherently diagnostic.
No
The device description explicitly states it is a "rapid chromatographic immunoassay," which is a physical test strip that detects hCG in urine. 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 it's for the "qualitative detection of human Chorionic Gonadotropin (hCG) in the urine to aid in the early detection of pregnancy." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The description reinforces this by calling it a "rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine."
- Nature of the Test: The test works by detecting a specific substance (hCG) in a biological fluid (urine) to provide information about a physiological state (pregnancy). This is the core function of an IVD.
N/A
Intended Use / Indications for Use
Atlas Home Pregnancy Test, Midstream (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the urine to aid in the early detection of pregnancy.
Atlas Home Pregnancy Test (Midstream Format) is a home use (OTC) rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in the urine to aid in the early detection of pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
Home Pregnancy Test (Midstream Format) is an OTC single use rapid Atlas chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
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
Not Found
Intended User / Care Setting
Home Use (OTC)
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 above comparison is based on the Performance Testing - Bench study and clinical studies results included in this file. The study includes results accuracy conducted for both tests. The results show that Atlas Home Pregnancy Test compares well with the ACON™ One Step Pregnancy Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Detection limit: 25 mIU/ml
Accuracy: ≥99%
Specificity: No interference when tested with FSH, LH & TSH
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
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
0
K10276 D
AUG - 3 2011
510(k) Summary
1- Name and Address of Submitter
| The submitter's name: | Atlas Medical. |
|---|---|
| Address: | Atlas Medical, P.O. Box 204, |
| Sahab Free Zone Area, King Abdullah II Industrial City | |
| Amman 11512 Jordan. | |
| Tel: +962 6 40 26 468 | |
| Fax: +962 6 40 22 588 | |
| Email: quality.assurance4@atlas-site.co.uk | |
| Contact person: Noor Al-ahwal (QA Manager) |
This 510(k) summary was prepared on April 26th, 2011.
2- The name of the device
| Trade Name: | Atlas Home Pregnancy Test (Midstream format) |
|---|---|
| Common Name: | Pregnancy Test Kit, OTC. |
| Classification Name: | Kit, Test, Pregnancy, hCG, Over The Counter. |
| Device classification (Regulation Number): | 21 CFR Part 862.1155. |
| Regulatory Class: | II |
| Product Code: | LCX. |
| Panel: | 75 - Clinical Chemistry. |
| Format: | Midstream. |
3- Equivalence legally marketed device:
Atlas Home Pregnancy Test (Midstream Format) has been determined to be substantially equivalent to ACON™ One Step Test Device (K993317) currently in commercial distribution by Acon Laboratories, Inc.
4- Device description:
Home Pregnancy Test (Midstream Format) is an OTC single use rapid Atlas chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
King Abdullah The Second Industrial Estate, Street 19, Sahab Free Zone Area, P.O. Box: 201 Amman 11512 Jordan. Tel: +962 (0)6 4026468, Fax: +962 (0)6 4022588
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5- Intended use:
Atlas Home Pregnancy Test, Midstream (Urine) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in the urine to aid in the early detection of pregnancy.
6- Test Format:
Atlas Home Pregnancy Test is a Midstream format.
7- Test Principle:
Atlas Home Pregnancy Test (Midstream Format) is a rapid qualitative chromatographic assay, utilizes a combination of antibodies including hCG antibody to detect elevated levels of hCG. The test consists of a membrane coated with a polyclonal anti-hCG Abs as a test line, colored conjugate of mouse anti-hCG Abs colloidal gold conjugate act as a conjugate releasing pad, and the control line which contains a monoclonal goat anti-mouse Abs. When the urine sample is applied it will react with the colored conjugate in the conjugate releasing pad, then the mixture migrates upwards on the membrane chromatographically to react with hCG Abs on the membrane and generates a colored band, which indicates a positive result. As the mixture continues to migrate across the membrane to the goat anti-mouse region colored band will always appear to serve as a procedural control and to show that the test has been performed properly.
8- Major ingredients of Atlas Home Pregnancy Test (Midstream Format):
- Mouse anti- hCG -
- -Polyclonal anti-hCG Abs
- Monoclonal goat anti-mouse Abs -
- -Colloidal gold conjugated with mouse anti-hCG Abs.
9- Comparison with predicate device
Feature Comparison of Atlas Home Pregnancy Test (Midstream Format) with ACONTM Midstream Pregnancy Test.
| Parameter | Atlas Home Pregnancy Test
(Midstream Format) | ACONTM One Step Pregnancy
Test Device. (K993317) |
|--------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Intended Use | Home Use (OTC) test for the
qualitative detection of human
chorionic gonadotropin (hCG) in
urine | Home Use (OTC) test for the
qualitative detection of human
chorionic gonadotropin (hCG) in
urine |
| Indication for Use | Early detection of pregnancy | Early detection of pregnancy. |
| Specimen | Urine | Urine |
| Format | Test strip in a midstream device. | Test strip in a plastic device. |
| Methodology | Colloidal Gold Immunoassay
(Membrane particle assay) | Colloidal Gold Immunoassay
(Membrane particle assay) |
| Storage | 36-86°F | 59-86°F |
| Test Time | 3 minutes. | 3 minutes. |
King Abdullah The Second Industrial Estate, Street 19, Sahab Free Zone Area, P.O. Box: 201 Amman 11512 Jordan. Tel: +962 (0)6 4026468, Fax: +962 (0)6 4022588
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| Detection limit | 25 mIU/ml | 25 mIU/ml |
|---|---|---|
| Accuracy | ≥99% | ≥99% |
| Specificity | No interference when tested with FSH, LH & TSH | No interference when tested with FSH, LH & TSH |
| Standardization | WHO Third International Standard. | WHO Third International Standard. |
The above comparison is based on the Performance Testing - Bench study and clinical studies results included in this file. The study includes results accuracy conducted for both tests. The results show that Atlas Home Pregnancy Test compares well with the ACON™ One Step Pregnancy Test.
Conclusion
Atlas Home Pregnancy .Test (Midstream Format) is found to be substantially equivalent to the predicate device (ACON1M One Step Pregnancy Test).
Risk Analysis as per ISO14971 "Medical Devices - Application of risk management to medical devices" has been conducted on Atlas Home Pregnancy Test (Midstream Format) and had showed that possible risks encountered with the use of the product is very mimimal and the benefits outweigh risks by far.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three figures standing underneath it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
AUG 0 3 2011
Atlas Medical c/o Nour Al-ahwal King Abdullah II Industrial Estate Street 19, Sahab Free Zone Area P.O. Box 201 Amman, Jordan 11512
K102760 Re:
Trade Name: Atlas Home Pregnancy Test (Midstream Format) Regulation Number: 21 CFR §862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: July 23, 2011 Received: July 26, 2011
Dear Nour Al-ahwal:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to paremarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its than the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Enclosure
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Indication for Use
510(k) Number (if known): 长 1027 6 0
Device Name: Atlas Home Pregnancy Test. (Midstream Format)
Indication for Use:
Atlas Home Pregnancy Test (Midstream Format) is a home use (OTC) rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in the urine to aid in the early detection of pregnancy.
Prescription Use NO (21 CFR Part 801 Subpart D) And/or
Over The Counter Use Yes (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUO ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Rute Olson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510 (k) k 102760