(95 days)
The Poly stat hCG Dipstick Test is intended to detect the presence of human chorionic gonadotrpin (hCG) in the urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA for "The Poly stat hCG Dipstick Test." While it states the device's indications for use and classification, it does not include detailed information regarding acceptance criteria, study design, or performance data that would typically be required to answer the requested questions. This document is an approval letter, not the submission itself.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or stated as missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. | Not specified in this document. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified in this document.
- Qualifications of Experts: Not specified in this document.
4. Adjudication method for the test set:
- Not specified in this document.
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:
- Not specified in this document. This is a HCG dipstick test, not an AI-assisted diagnostic device, so an MRMC study related to AI assistance is unlikely and not applicable based on the device description.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not specified in this document. As it's a dipstick test, it's inherently a standalone diagnostic and not an "algorithm only" device in the typical sense of AI/software. Performance would be assessed inherently as standalone.
7. The type of ground truth used:
- Not specified in this document. For an hCG test, ground truth would typically be established by laboratory reference methods (e.g., quantitative hCG assays) or clinical outcomes.
8. The sample size for the training set:
- Not specified in this document.
9. How the ground truth for the training set was established:
- Not specified in this document.
Conclusion:
The provided document is an FDA approval letter (510(k) clearance) for a human chorionic gonadotropin (hCG) dipstick test. It confirms the device's substantial equivalence to a predicate device and its intended use for early pregnancy detection. However, this letter does not contain the detailed study results, acceptance criteria, sample sizes, or ground truth establishment methods that would have been part of the original 510(k) submission. To answer the specific questions, one would need to access the full 510(k) submission (K021386) submitted by Alidex, Inc.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 0 5 2002
Ms. Helen Landicho Director RA/QS Alidex, Inc. 12277 134th Ct. NE Suite 100 Redmond, WA 98052
:
Re: K021386
Trade/Device Name: The Poly stat hCG Dipstick Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: July 17, 2002 Received: July 19, 2002
Dear Ms. Landicho:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrl/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 12.0 INDICATIONS FOR USE STATEMENT
510(k) Number: ___ K021386
Device Name: The Poly stat hCG Dipstick Test
Indications For Use:
The Poly stat hCG Dipstick Test is intended to detect the presence of human chorionic gonadotrpin (hCG) in the urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.
(PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
V Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
P. Bernhardt 129. Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices K CD 1386 510(k) Number _
Alidex, Inc.
§ 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.