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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Atlas Home Pregnancy Test (Midstream format), based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance	Study Proving Performance
Detection limit: 25 mIU/ml	25 mIU/ml	Performance Testing - Bench study and clinical studies
Accuracy: ≥99%	≥99%	Performance Testing - Bench study and clinical studies
Specificity: No interference when tested with FSH, LH & TSH	No interference when tested with FSH, LH & TSH	Performance Testing - Bench study and clinical studies
Standardization: WHO Third International Standard	WHO Third International Standard	Performance Testing - Bench study and clinical studies

Study Details

2. Sample size used for the test set and the data provenance:

The document states "clinical studies results included in this file" but does not provide specific sample sizes for the test set.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The submitter is based in Jordan, but the location of the clinical study participants is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document does not provide details on how ground truth was established, including the number or qualifications of any experts involved.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified. The document does not describe any adjudication method for establishing ground truth.

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, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test (pregnancy test) meant for direct consumer use (OTC) and does not involve human "readers" in the context of image interpretation or similar roles where AI assistance would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, this is essentially a standalone (algorithm only) test. As an Over-The-Counter (OTC) home pregnancy test, the performance measured is the device's ability to detect hCG without any "human-in-the-loop" interpretation beyond reading the result lines as positive or negative. The reported accuracy, detection limit, and specificity are inherent to the device's mechanism.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly stated on how ground truth was established for the clinical studies. For pregnancy tests, ground truth typically involves confirmation through a laboratory-based quantitative hCG test or clinical confirmation of pregnancy (e.g., ultrasound, follow-up). The document only mentions "clinical studies results" without detailing the ground truth method.

8. The sample size for the training set:

Not applicable/Not provided. As a chromatographic immunoassay, this device does not typically involve "training sets" in the same way machine learning algorithms do. Its performance is based on its chemical and biological composition and reaction.

9. How the ground truth for the training set was established:

Not applicable/Not provided. See the explanation for point 8.

Summary

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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 CityAmman 11512 Jordan.
	Tel: +962 6 40 26 468Fax: +962 6 40 22 588Email: quality.assurance4@atlas-site.co.ukContact 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:

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 PregnancyTest Device. (K993317)
Intended Use	Home Use (OTC) test for thequalitative detection of humanchorionic gonadotropin (hCG) inurine	Home Use (OTC) test for thequalitative detection of humanchorionic gonadotropin (hCG) inurine
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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Page 2 -

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:

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

Regulation Number and Section

§ 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.