(22 days)
The Inverness Medical™ Early Pregnancy Test is intended for use by lay consumers for the qualitative detection of hCG in urine as an aid in the detection of early pregnancy.
The modified device is substantially equivalent to the previously cleared Selfcare Predicate Device Early Pregnancy Test (K960436). The primary modifications are changes to the strip width and specimen sample size. Corresponding dimensional changes have been made to the housing to accommodate the narrower strip design. The modified device has the same technological characteristics as the legally marketed predicate device employing monoclonal antibodies for immunochromatographic assay.
The provided text describes the 510(k) summary for the Inverness Medical™ Early Pregnancy Test. However, it does not provide specific acceptance criteria or detailed study results in quantifiable metrics. Instead, it makes general statements about testing and substantial equivalence.
Here's an attempt to answer your questions based only on the provided text, acknowledging where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|
| "Acceptance criteria were based on the specifications cleared for the predicate device" | "Test results showed substantial equivalence." "Testing involved safety testing from the risk analysis. Other evaluations included laboratory studies for repeatability, sensitivity, and interferences, and field evaluations for professional and consumer accuracy." |
Specific quantitative acceptance criteria (e.g., sensitivity >X%, specificity >Y%) and their corresponding measured performance values are not provided in the document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample size used for the test set in any of the described evaluations (repeatability, sensitivity, interferences, professional and consumer accuracy).
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The device is for "lay consumers for the qualitative detection of hCG in urine," suggesting the "consumer accuracy" evaluations might have involved real users, but the specifics of ground truth determination (e.g., confirmation by a clinical lab) are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for the test set.
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
This section is not applicable as the device described is an "Early Pregnancy Test Device" employing "immunochromatographic assay," which is a diagnostic test kit and not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or complex data with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable in the context of an immunochromatographic assay for pregnancy. The device itself is "standalone" in the sense that it provides a result, but it doesn't involve an "algorithm" in the way an AI medical device would. "Human-in-the-loop performance" would be similar to "consumer accuracy" and "professional accuracy," which were evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the ground truth for hCG detection would be established by reference laboratory methods or clinical confirmation of pregnancy, but it does not explicitly state the specific type of ground truth. For a pregnancy test, the ground truth for hCG levels is typically determined by quantitative blood tests or confirmed clinical pregnancy.
8. The sample size for the training set
The document does not describe a "training set" in the context of machine learning or AI. The "testing verification and validation testing activities" relate to traditional device performance evaluation, not AI model development.
9. How the ground truth for the training set was established
Not applicable, as no training set (in the AI/ML sense) is mentioned.
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DEC 1 8 2001
510(k) Summary (As Required by 21 C.F.R. §807.92)
K013907 Avril Murray, MSc. Submitted by: Product Development Manager Cambridge Diagnostics Ireland Limited Mervue Business Park Galway, Ireland. Phone 011 353 91 741976, Fax 011 353 91 752551 e-mail: avril.murray@cambridgediagnostics.ie Date of summary November 23, 2001 Inverness Medical™ Early Pregnancy Test Device name Common name Early Pregnancy Test Classification Name Regulation Number Classification names 862.1155(a) Kit, Test, Pregnancy, hCG, Over the Counter The modified device is substantially equivalent to the previously cleared Selfcare Predicate Device Early Pregnancy Test (K960436). The primary modifications are changes to the strip width and specimen sample Modifications size. Corresponding dimensional changes have been made to the housing to accommodate the narrower strip design. The modified device has the same intended use as the legally marketed predicate Intended Use device. The Inverness Medical™ Early Pregnancy Test is intended for use by lay consumers for the qualitative detection of hCG in urine as an aid in the detection of early pregnancy. Technological The modified device has the same technological characteristics as the legally marketed predicate device employing monoclonal antibodies for Characteristics immunochromatographic assay. Testing Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device. Testing involved safety testing from the risk analysis. Other evaluations included laboratory studies for repeatability, sensitivity, and interferences, and field evaluations for professional and consumer accuracy. Acceptance criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three curved lines representing its wings or feathers. The eagle is positioned within a circular frame, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 8 2001
Ms. Avril Murray MSc Product Development Manager Cambridge Diagnostics Ireland, Ltd. Mervue Industrial Estate Galway, Ireland
Re: K013907 Trade/Device Name: The Inverness Medical™ Early Pregancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gondotropin (HCG) test system Regulatory Class: Class II Product Code: LCX; Dated: November 23, 2001 Received: November 26, 2001
Dear Ms. Murray:
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 1 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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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3.1 ODE Indications Statement
Indications for Use Statement
510(k) Number KO13907 (if known)
The Inverness Medical™ Early Pregnancy Test Device Name
Indications for Use
The Inverness Medical™ Early Pregnancy Test is intended for use by lay consumers for the qualitative detection of hCG in urine as an aid in the detection of early pregnancy.
Thoman E. Dote Le Jean Cooper
sion Sign-Off vision of Clinical Laboratory Devices Kol 3907 510(k) Number_
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
§ 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.