(21 days)
The InstaRead™ Lithium System is intended to measure lithium blood levels in whole blood (fingerstick or venous). Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).
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Here's the information about the acceptance criteria and the study for the InstaRead™ Lithium System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain specific acceptance criteria for performance metrics (like accuracy, precision, or comparison to a predicate device). It primarily focuses on the regulatory approval for marketing.
However, based on the context of a "Lithium test system," typical acceptance criteria would involve demonstrating equivalency to a legally marketed predicate device in terms of:
- Accuracy/Correlation: How well the device's measurements correlate with a reference method or predicate device.
- Precision/Reproducibility: The consistency of results when the same sample is tested multiple times.
- Linearity/Range: The ability of the device to accurately measure lithium across its claimed analytical range.
Since these specific criteria and their actual performance values are not detailed in the provided FDA letter, the table below reflects what would typically be expected in such a submission, but with "Not Specified" for the actual values. The document states a "substantial equivalence determination," implying these criteria were met.
| Acceptance Criteria Category | Specific Metric (Example) | Acceptance Threshold (Example) | Reported Device Performance |
|---|---|---|---|
| Accuracy / Method Comparison | Correlation Coefficient (r) | >0.95 vs. predicate/reference | Not Specified (Implied as meeting substantial equivalence) |
| Bias (Mean Difference) | Within CLIA/CAP acceptable limits | Not Specified (Implied as meeting substantial equivalence) | |
| Precision | Coefficient of Variation (CV%) | < 5-10% (depending on concentration) | Not Specified (Implied as meeting substantial equivalence) |
| Linearity | Linear Range | Accurately measures within claimed range | Not Specified (Implied as meeting substantial equivalence) |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The provided document does not specify the number or qualifications of experts used to establish ground truth for a test set. For an in vitro diagnostic device like a lithium test system, "ground truth" would typically be established by a reference laboratory method or a predicate device, rather than human expert opinion on images or clinical assessments.
4. Adjudication Method for the Test Set
The provided document does not specify any adjudication method for a test set. This is generally not applicable for a chemical assay device where comparisons are made to quantitative reference values.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided document does not mention or imply that an MRMC comparative effectiveness study was done. This type of study is more relevant for diagnostic imaging systems where human readers interpret images, rather than for an in vitro diagnostic device that produces quantitative measurements directly.
6. Standalone (Algorithm Only) Performance Study
The provided document does not explicitly describe a standalone performance study as would be typically understood for an AI algorithm. However, the entire submission for an in vitro diagnostic device like the InstaRead™ Lithium System essentially is a "standalone" performance evaluation of the device itself (the "algorithm" being the chemical and optical measurement process) to determine its accuracy, precision, and other analytical characteristics against reference methods or predicate devices. There is no mention of a human-in-the-loop component for this specific measurement system.
7. Type of Ground Truth Used
The provided document does not explicitly state the type of ground truth used. For a lithium test system, the ground truth would almost certainly be established through:
- Reference Laboratory Methods: Highly accurate and precise laboratory methods (e.g., atomic absorption spectrometry, inductively coupled plasma mass spectrometry) to determine actual lithium concentrations.
- Predicate Device Comparison: Measurements by a legally marketed and established lithium test system used as a comparator.
8. Sample Size for the Training Set
The provided document does not specify the sample size for a training set. For a chemical assay device, there isn't typically a "training set" in the same way as there would be for an AI algorithm that learns from data. The device's calibration and internal algorithms are developed and validated during the device's engineering and manufacturing process, using controlled samples.
9. How the Ground Truth for the Training Set Was Established
The provided document does not specify how ground truth for a "training set" (as understood in machine learning) was established. If referring to the establishment of calibration curves or internal reference values for the device, this would typically involve:
- Certified Reference Materials (CRMs): Samples with known, accurately measured concentrations of lithium.
- Primary Calibrators: Solutions prepared with high purity lithium salts to establish the device's response curve.
- Comparison to Reference Methods: Using samples analyzed by highly accurate reference laboratory methods to "train" or validate the device's measurement system.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings forming three curved lines.
MAR 4 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Erika Ammirati Regulatory Consultant Akers Biosciences, Inc. 201 Grove Road Thorofare NJ, 08086
K050338 Re:
Trade/Device Name: InstaRead™ Lithium System Regulation Number: 21 CFR 862.3560 Regulation Name: Lithium test system Regulatory Class: Class II Product Code: JIH Dated: January 31, 2005 Received: February 14, 2005
Dear Ms. Ammirati:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated 776, 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). and ovening the refore, 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 ican 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 5 [0(k) I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification: "The PDT Intentig sification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you desire specific information advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may oount outer generational 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/industry/support/index.html
Sincerely yours,
Jean M. Coogen MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K050338
InstaRead™ Lithium System: Device Name
The InstaRead™ Lithium System is intended to measure Indications For Use: lithium blood levels in whole blood (fingerstick or venous). Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol Benson
Division: 3-01
oldsonosile the online and Safety Device I
K05033
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§ 862.3560 Lithium test system.
(a)
Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).(b)
Classification. Class II.