(219 days)
The CAC Bio-Chem AnalyzerTM is a microprocessor-controlled instrument for the quantitative determination of specific analytes in whole blood and plasma. The instrument deploys single-use, single analyte disposable test books of the following test analyte: potassium. Potassium measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of conditions characterized by low or high blood potassium levels. The CAC Bio-Chem Analyzer™ is a point-of-care device intended for hospital-use settings.
The CAC Bio-Chem AnalyzerTM is a microprocessor-controlled instrument for the quantitative determination of specific analytes in whole blood and plasma. The instrument deploys single-use, single analyte disposable test books of the following test analyte: potassium.
Here's an analysis of the provided text regarding acceptance criteria and study details for the CAC Bio-Chem Analyzer™, formatted as requested:
Acceptance Criteria and Study Details for CAC Bio-Chem Analyzer™
The provided document is a 510(k) clearance letter from the FDA. It does not contain detailed information about specific acceptance criteria, study design, or performance metrics. It primarily states that the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, many sections of your request cannot be fully answered directly from this document. However, based on the nature of a 510(k) submission for an in vitro diagnostic device (specifically a potassium test system), we can infer the types of studies and acceptance criteria that would have been required for substantial equivalence, even if the specifics are not present here.
1. Table of Acceptance Criteria and Reported Device Performance
As the specific acceptance criteria and performance data are not detailed in this clearance letter, this table cannot be populated with precise values. For a potassium test system, typical acceptance criteria would relate to:
| Metric Type | Acceptance Criteria (Likely for a Potassium Test System) | Reported Device Performance (Not available in provided text) |
|---|---|---|
| Accuracy (Bias) | Agreement with a reference method (e.g., within X% or Y mmol/L) | Not reported in provided document |
| Precision (Reproducibility) | Within-run, between-run, and total precision (e.g., CV% < X%) | Not reported in provided document |
| Linearity/Reportable Range | Performance across the specified analytical measurement range | Not reported in provided document |
| Interferences | No significant interference from common substances (e.g., hemolysis, lipemia, bilirubin) | Not reported in provided document |
| Carry-over | Negligible carry-over between samples | Not reported in provided document |
| Method Comparison | Strong correlation with a predicate device or reference method (e.g., R² > 0.95 or specific regression statistics) | Not reported in provided document |
| Reference Interval | (If applicable and defined by the manufacturer) | Not reported in provided document |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size, country of origin, or whether the study was retrospective or prospective. For a 510(k) for an in vitro diagnostic device, a clinical validation study demonstrating performance on patient samples (or samples mimicking patient samples) would be expected. The sample size would be determined to show statistical significance for the performance claims.
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)
This is not applicable to an in vitro diagnostic device like a potassium test system. Ground truth is typically established by:
- A reference method (e.g., flame photometry, ion-selective electrode on a large laboratory analyzer) considered the "gold standard."
- Comparison with a legally marketed predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable in the context of an in vitro diagnostic device for quantitative chemical analysis. Adjudication methods are typically used for subjective assessments (e.g., image interpretation where multiple experts might disagree).
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 applicable. This is not an imaging device or an AI-assisted diagnostic tool that involves human "readers." It's a quantitative chemical analyzer.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This device is a standalone instrument (CAC Bio-Chem Analyzer™) for quantitative determination. Its performance inherently represents standalone algorithm-only performance in terms of chemical analysis. Its output (potassium levels) does not typically require human interpretation in the same way an image or complex waveform might. The "human-in-the-loop" would be the clinician using the result to guide treatment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a potassium test system, the ground truth would be established by:
- Measurements obtained from a recognized reference method (e.g., highly accurate laboratory electrolyte analyzer using an established measurement principle).
- Comparative measurements against a predicate device that has already been cleared or approved by the FDA and is considered accurate and reliable.
8. The sample size for the training set
The document does not provide any information about a "training set." For an in vitro diagnostic device like this, the development process would involve extensive R&D and calibration, but the clinical validation (performance study) would be distinct from a "training set" in the machine learning sense. Data used during the development and calibration of the instrument's reagents and measurement algorithms would be analogous to a training set, but its size is not specified.
9. How the ground truth for the training set was established
Similar to point 7, ground truth for any internal development/calibration of the device would be established using:
- High-purity reference materials with known concentrations of potassium.
- Certified reference methods to define the true concentration of analytes in calibrator and control materials.
- Comparison to established predicate methods during the design and optimization phases.
Summary of Limitations from the Provided Document:
The provided FDA 510(k) clearance letter is a regulatory approval document. It confirms that the FDA found the device "substantially equivalent" based on information submitted by the manufacturer. It does not include the detailed scientific and clinical study reports that contain the specific acceptance criteria, performance data, sample sizes, and ground truth establishment methods. These details would be found within the 510(k) submission itself, which is typically proprietary at the time of submission and not fully disclosed in the public clearance letter.
{0}------------------------------------------------
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 graphic of three parallel lines that curve and resemble a human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 8 2004
Mr. Charles McBrairty Execututive Vice President R&D Clinical Analysis Corporation 2100 Quaker Pointe Drive Quakertown, PA 18951-2182
K040750 Re:
Trade/Device Name: CAC Bio-Chem Analyzer™ Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium test system Regulatory Class: Class II Product Code: CEM Dated: October 7, 2004 Received: October 8, 2004
Dear Mr. McBrairty:
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 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).
{1}------------------------------------------------
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with anow you to ough finding of substantial equivalence of your device to a legally promatication of the results in a classification 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 dostre specific mission and advertising of your device, please contact the Office of or questions on the promise Evaluation and Safety at (301) 594-3084. 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 I va may ookun battle getecturers, 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,
Sean M. Cooper, MS, DVM.
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K040750
Device Name: CAC Bio-Chem AnalyzerTM
Indications For Use:
malousono . C. C. C. C. . AnalyzerTM is a microprocessor-controlled rne the blow onem instrument for the quantitative ercermination of specific analytes in whole blood and plasma. deceimination or bposs single-use, single analyte disposable ine instrument deploys books of the following test analyte: potassium
Potassium measurements obtained by this device are used to rocusbram moderalyte balance in the diagnosis and treatment monitir ses conditions characterized by low or high blood potassium levels.
The CAC Bio-Chem Analyzer™ is a point-of-care device intended for hospital-use settings.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic
510(k) K040750
Page 1 of
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.