(41 days)
The IBL Estradiol ELISA test kit is intended for the in vitro determination of estradiol, an estrogenic steroid, in human serum and plasma. Estradiol measurements are used in the diagnostics and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
Not Found
This FDA 510(k) clearance letter dated November 24, 1997, for the KMI Diagnostics, Inc. 17 ß-Estradiol (ELISA) test kit, does not contain the detailed information necessary to complete a comprehensive table of acceptance criteria, device performance, and study characteristics.
The document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, allowing the manufacturer to market the device. It states the "Indications for Use" but does not provide specific performance metrics, study designs, or ground truth methodologies.
Therefore, I cannot fully address the request with the information provided.
However, I can extract the following limited information:
Indications for Use (from the document):
"The IBL Estradiol ELISA test kit is intended for the in vitro determination of estradiol, an estrogenic steroid, in human serum and plasma. Estradiol measurements are used in the diagnostics and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy."
Based on the typical regulatory requirements for ELISA kits at the time, and the "substantial equivalence" claim, the acceptance criteria would generally refer to demonstrating comparable performance to an existing, legally marketed device (the predicate device). This would involve analytical performance studies rather than clinical efficacy studies on patient outcomes.
Here is what a hypothetical response might look like if the requested information were present in the document, along with an explanation of why I cannot fill it based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Hypothetical) | Acceptance Criteria (Hypothetical) | Reported Device Performance (Not Available in Document) |
|---|---|---|
| Analytical Sensitivity (Detection Limit) | Should be ≤ X pg/mL | [Information not provided in the document] |
| Analytical Specificity (Cross-reactivity) | Cross-reactivity to interfering substances ≤ Y% | [Information not provided in the document] |
| Precision (Intra-assay CV) | CV ≤ Z% | [Information not provided in the document] |
| Precision (Inter-assay CV) | CV ≤ A% | [Information not provided in the document] |
| Accuracy (Correlation with reference method) | R² ≥ 0.95 with established reference method | [Information not provided in the document] |
| Linearity of Dilution | % Recovery within B% of expected value | [Information not provided in the document] |
| Measuring Range | X to Y pg/mL | [Information not provided in the document] |
Explanation: The provided 510(k) summary letter does not include specific analytical performance metrics or the acceptance criteria for these metrics. The letter confirms "substantial equivalence" but does not detail the data supporting this claim.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not available in the document.
- Data Provenance: Not available in the document (e.g., country of origin, retrospective/prospective).
Explanation: The document does not describe the specific study data used to demonstrate equivalence, including the number of samples or their origin. For ELISA kits, this would typically involve analytical samples (spiked samples, patient samples compared to a reference method).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not available in the document.
- Qualifications of Experts: Not applicable/Not available in the document.
Explanation: For an in vitro diagnostic (IVD) device like an ELISA kit, ground truth is typically established through a reference method (e.g., GC-MS, LC-MS/MS, or a well-established, previously cleared ELISA). It usually does not involve expert readers or adjudication in the same way an imaging or pathology device might.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not available in the document.
Explanation: As mentioned above, this type of device's "ground truth" is analytical, not based on expert review requiring adjudication.
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
- MRMC Study Done?: No.
- Effect Size: Not applicable.
Explanation: This is an immunoassay (ELISA) kit, not an AI-powered diagnostic imaging or pathology device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Done?: Yes, the device itself is a standalone laboratory test.
Explanation: The ELISA kit is a laboratory test run by trained technicians. Its performance is measured directly, without a human-in-the-loop interaction in the diagnostic interpretation once the assay is complete.
7. The type of ground truth used
- Type of Ground Truth: Not specified in the document.
Explanation: Typically for an ELISA, the ground truth would be established by comparing results from the investigational device to a recognized "gold standard" or reference method (e.g., Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS/MS), or a well-validated predicate immunoassay). The document does not specify which was used.
8. The sample size for the training set
- Sample Size for Training Set: Not relevant or available in the document.
Explanation: ELISA kits are developed using biochemical principles and reagents, not machine learning algorithms that require "training sets" in the AI sense. While method development involves optimization, it's not analogous to an AI training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set Established: Not relevant or available in the document.
Explanation: As above, this concept of a "training set" and its "ground truth" is not directly applicable to the development and validation of an ELISA assay in the context of this 1997 regulatory submission.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 24 1997
Mark A. Kowal . President KMI Diagnostics, Inc. 818 51st Avenue, NE Suite 101 55421 Minneapolis, Minnesota
Re : K973901 17 ß-Estradiol (ELISA) Regulatory Class: I .. . Product Code: CHP October 10, 1997 Dated: Received: October 14, 1997
Dear Mr. Kowal:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 requlation (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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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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KMI Diagnostics; Inc. ---------818 Sist Ave. NE Suite 101 Minneapolis, MN 55421 USA
Attachment I
Device Name: Estradiol ELISA Test Kit
Indications for Use
The IBL Estradiol ELISA test kit is intended for the in vitro determination of estradiol, an estrogenic steroid, in human serum and plasma. Estradiol measurements are used in the diagnostics and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
(Division Sign-Off)
Division of Clinical Laboratory Degies
510(k) Number. K973930
Mark Q. Kousf
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
rrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Phone: 1 (612) 572-9354
18
§ 862.1260 Estradiol test system.
(a)
Identification. An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.