(69 days)
The Poly stat hCG Test is intended to detect the presence of human chorionic gonadotropin (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 does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. It is a 510(k) clearance letter from the FDA for a diagnostic device, the Poly stat hCG Test.
However, based on the general nature of an hCG test and the context of a 510(k) submission, we can infer some typical acceptance criteria for such a device and what a study might generally involve, even if the specifics are not in this document.
Inferred Acceptance Criteria and General Study Design (Based on typical IVDDs, not explicitly in the provided text):
The FDA 510(k) clearance states: "We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass black in the 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)." This means the device demonstrated substantial equivalence to a predicate device, which would typically involve performance studies comparing the new device to the predicate and/or to a defined gold standard.
Here's an attempt to answer the questions based on what would typically be required for such a device, acknowledging that these specifics are NOT in the provided document:
1. A table of acceptance criteria and the reported device performance
Since the document does not provide specific acceptance criteria or reported performance metrics, here is an example of what such a table might contain for an hCG test:
| Acceptance Criteria Category | Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|---|
| Analytical Sensitivity | Detect hCG at ≥ 25 mIU/mL | Detected hCG at 20 mIU/mL |
| Analytical Specificity | No cross-reactivity with LH, FSH, TSH, etc. at specified concentrations | No cross-reactivity observed at tested concentrations |
| Accuracy (Clinical) | ≥95% agreement with predicate device or laboratory reference for positive and negative samples | 98% agreement with laboratory reference |
| Precision (Repeatability) | Consistent results for replicates of low, medium, and high hCG concentrations | CV < 5% for all tested concentrations |
| Limit of Detection (LoD) | LoD ≤ 20 mIU/mL | LoD = 18 mIU/mL |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size or data provenance for the test set. For an hCG test, a typical sample size for a clinical study to establish accuracy and compare to a predicate device might range from 200 to 500 patient samples, potentially including a mix of early pregnancy, late pregnancy, and non-pregnant urine samples. The data provenance would likely be prospective collection from multiple clinical sites (e.g., doctor's offices, clinics) within the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For an hCG test, the ground truth is typically established through a laboratory reference method, such as a quantitative serum hCG assay or another FDA-cleared qualitative urine hCG assay, rather than relying on multiple human experts interpreting a diagnostic image. Therefore, the "experts" would be trained laboratory technicians or clinical professionals performing these reference methods, and their qualifications would include appropriate certifications (e.g., Medical Technologist, Clinical Laboratory Scientist) and experience in a clinical laboratory setting. The number is usually not about a consensus of multiple experts on individual cases, but rather the consistent and accurate application of the reference method.
4. Adjudication method for the test set
In the context of an hCG test and a laboratory reference, formal adjudication methods like "2+1" or "3+1" (common in imaging studies where human interpretation can vary) are generally not applicable. The ground truth is typically established by the results of the reference assay. Any discrepancies between the device under test and the reference method would be investigated, possibly through repeat testing or by reviewing patient charts/clinical outcomes.
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 is not relevant to a diagnostic test like the Poly stat hCG Test. This type of study is specifically designed for evaluating diagnostic imaging devices that require human interpretation, often with AI assistance. The Poly stat hCG Test is a qualitative in-vitro diagnostic device that provides a direct result (e.g., color change indicating positive or negative), not an image for human interpretation that could be assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance of the Poly stat hCG Test itself is inherently "standalone" in the sense that the test produces a result based on its chemical reactions, without human interpretation of a complex image or data. The "human-in-the-loop" aspect is limited to performing the test correctly and reading the visible reaction as positive or negative. The study would assess how accurately the device's inherent mechanisms detect hCG.
7. The type of ground truth used
The primary ground truth for an hCG test would typically be:
- Quantitative Serum hCG Assay: Considered the gold standard for hCG measurement.
- Clinical Outcomes Data: Confirmation of pregnancy via obstetrician diagnosis, ultrasound, or follow-up.
- FDA-cleared Predicate Device/Laboratory Reference Method: Often used for substantial equivalence claims.
8. The sample size for the training set
The document does not mention a training set. For a simple qualitative IVD like an hCG test, "training set" is usually not applicable in the same way it is for AI/ML algorithms. Device development involves numerous experiments and optimizations (e.g., reagent concentrations, membrane characteristics) which could be considered an iterative 'training' process, but not a formal data training set in the AI sense. The performance characteristics are established through analytical and clinical validation studies.
9. How the ground truth for the training set was established
As noted above, a formal training set with established ground truth, as understood in machine learning, is not a typical component of the development and validation of a qualitative in-vitro diagnostic test like the Poly stat hCG Test. Instead, device development relies on controlled experiments and characterization studies to optimize performance, with verification and validation against established reference methods.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 6 2001
Ms. Helen Landicho, RAC Director Regulatory Affairs Bion Diagnostic Sciences, Inc. 12277 134th Ct., N.E. Redmond, WA 98052
K012559 Trade/Device Name: The Poly stat hCG Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: August 6, 2001 Received: August 8, 2001
Dear Ms. Kindell:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass black in the 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 I ou may , and controls 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 If your device is exassinod (600 as 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 r lease be deviloed that I Draination that your device complies with other requirements of the Act that I Drillas intatutes and regulations administered by other Federal agencies. You must or any I catales and registered and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quind) 05 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/cdrh/dsma/dsmamain.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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oty stat hCG Test
SECTION 12.0 INDICATIONS FOR USE STATEMENT
510(k) Number: K012559
Device Name: The Poly stat hCG Test
Indications For Use:
The Poly stat hCG Test is intended to detect the presence of human chorionic gonadotropin (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)
Kesia Alexander for Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012559
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
lion Diagnostic Sciences, 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.