(68 days)
Not Found
No
The device description details a purely chemical and mechanical process for determining cholesterol levels, with no mention of computational analysis, algorithms, or learning processes.
No.
The device described is a control solution intended to monitor the performance of a cholesterol test, not to treat a medical condition.
No
This device is described as "Assayed Total Cholesterol Controls," which are used to monitor the performance of a cholesterol test. It does not perform the diagnostic determination itself, but rather ensures the accuracy of another diagnostic device.
No
The device description clearly details physical components like polymer solutions, absorbent pads, enzyme pads, flow delay pads, and a measurement zone with immobilized dyes and enzymes. It describes a chemical reaction and color change read from a physical scale, indicating a hardware-based test.
Based on the provided text, the device described, the ENA C T™ Assayed Total Cholesterol Controls, is an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use explicitly states that the controls are used to "monitor the performance of the test" which is the ENA-C.T™ Total Cholesterol Test. The ENA-C.T™ Total Cholesterol Test itself is described as an "instrument-free enzymatic assay for the quantitative determination of cholesterol in fingerstick whole blood for use by physicians to screen for elevated cholesterol". This clearly indicates that the controls are used in the context of an in vitro diagnostic procedure (testing blood outside the body).
- Device Description: The description details the composition of the controls (polymer solutions containing cholesterol from non-human plasma) and how they are used with the ENA·C·T™ Total Cholesterol Test device. The process involves adding the control to the device, which then undergoes enzymatic reactions and color development to indicate the cholesterol level. This entire process is performed in vitro.
- Function: The primary function of the controls is to ensure the proper performance and accuracy of the ENA·C·T™ Total Cholesterol Test, which is an IVD. Controls are a standard component of quality control for IVD tests.
- Predicate Device: The mention of a predicate device, K905405; ChemTrak, Inc. AccuMeter® Cholesterol Controls, further supports the classification as an IVD. Predicate devices are typically other legally marketed devices of the same type, and in this case, the predicate is also a cholesterol control, which is a type of IVD accessory.
Therefore, the ENA C T™ Assayed Total Cholesterol Controls are an IVD because they are reagents/materials intended for use in an in vitro diagnostic procedure (the ENA·C·T™ Total Cholesterol Test) to monitor the performance of that test.
N/A
Intended Use / Indications for Use
ENA C T™ Assayed Total Cholesterol Controls are intended for exclusive use with the ENA-C.T™ Total Cholesterol Test to monitor the performance of the test at the medical decision points in the determination of elevated cholesterol. The ENA-C-T™ Total Cholesterol Test is an instrumentfree enzymatic assay for the quantitative determination of cholesterol in fingerstick whole blood for use by physicians to screen for elevated cholesterol as a risk factor in coronary heart disease (CHD).
Product codes
APF.
Device Description
The ENA·C·T™ Assayed Total Cholesterol Controls are ready to use polymer solutions containing cholesterol from non-human (bovine) plasma. There are two levels of control included with each set: Level I is approximately 200 mg/dL and Level II is approximately 240 mg/dL. Assay range values for the ENA·C·T™ Assayed Total Cholesterol Controls are determined by testing the materials on multi-lot ENA·C·T™ Total Cholesterol devices which have been calibrated to produce results correlating to the Abell-Kendall reference method and are thus, traceable to the National Reference System for Cholesterol (NRS/CHOL). The controls are intended for exclusive use with the ENA·C·T™ Total Cholesterol Test.
The controls are used to ensure proper performance of the ENA·C·T™ Total Cholesterol Test and are tested in the same manner as a patient sample. Sufficient volume of the control is added to the ENA C TM Total Cholesterol Test device in the sample well. A self-actuating siphon, in turn, transfers the control to an absorbent pad located immediately below the "START" window. The control-saturated pad shows through the clear window as a yellow indicator, signaling that enough volume has been added and that the analytical process has been initiated. The control solution subsequently flows into an enzyme pad containing cholesterol esterase and cholesterol oxidase which completely convert cholesterol and cholesterol esters into cholestenone and hydrogen peroxide. A flow delay pad restricts passage of the control solution to permit completion of the enzymatic reactions. Subsequently, the control solution flows into the measurement zone where colorless dyes and the enzyme peroxidase are immobilized on a thin fabric layer.
The hydrogen peroxide generated from the cholesterol in the control solution converts the colorless dyes into a blue color bar, the length of which is proportional to the amount of hydrogen peroxide, and in turn, cholesterol in the control. The bar grows until a precise amount of solution has completely filled the measurement zone and "End/Q. A." draw zone. This draw zone turns green at the end of the procedure when the cholesterol converting enzymes dissolved in the solution react with control cholesterol contained in the draw zone. The appearance of a green color signals that the test is complete and that reagents were active. The total cholesterol concentration is directly read from the factory calibrated scale on the device. Results outside the linear measurement range of the ENA·C·T™ Total Cholesterol Test cannot be reported since the printed scale on the device only covers the range between 120 and 360 mg/dL. The color formed is stable and may be read at any time within 48 hours.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
960378
V960378
APF. - 3 159.
510(k) SUMMARY
ACTIMED LABORATORIES, INC. ENA C.T™ Assayed Total Cholesterol Controls
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Susan McGeehan Manager, Quality Assurance ActiMed Laboratories, Inc. 5 Terri Lane Burlington, NJ 08016 Phone: (609) 387-7700, Ext. 119 Facsimile: (609) 387-2700
Contact Person: same as above
Date Prepared: January 25, 1996
Name of Device and Name/Address of Sponsor
ENA·C·T™ Assayed Total Cholesterol Controls
ActiMed Laboratories, Inc. 5 Terri Lane Burlington, NJ 08016
Classification Name
Quality Control Material
Predicate Device
ChemTrak, Inc. AccuMeter® Cholesterol Controls (K905405)
1
Intended Use and Indications for Use
ENA C T™ Assayed Total Cholesterol Controls are intended for exclusive use with the ENA-C.T™ Total Cholesterol Test to monitor the performance of the test at the medical decision points in the determination of elevated cholesterol. The ENA-C-T™ Total Cholesterol Test is an instrumentfree enzymatic assay for the quantitative determination of cholesterol in fingerstick whole blood for use by physicians to screen for elevated cholesterol as a risk factor in coronary heart disease (CHD).
Technological Characteristics and Substantial Equivalence
The ENA·C·T™ Assayed Total Cholesterol Controls are ready to use polymer solutions containing cholesterol from non-human (bovine) plasma. There are two levels of control included with each set: Level I is approximately 200 mg/dL and Level II is approximately 240 mg/dL. Assay range values for the ENA·C·T™ Assayed Total Cholesterol Controls are determined by testing the materials on multi-lot ENA·C·T™ Total Cholesterol devices which have been calibrated to produce results correlating to the Abell-Kendall reference method and are thus, traceable to the National Reference System for Cholesterol (NRS/CHOL). The controls are intended for exclusive use with the ENA·C·T™ Total Cholesterol Test.
The controls are used to ensure proper performance of the ENA·C·T™ Total Cholesterol Test and are tested in the same manner as a patient sample. Sufficient volume of the control is added to the ENA C TM Total Cholesterol Test device in the sample well. A self-actuating siphon, in turn, transfers the control to an absorbent pad located immediately below the "START" window. The control-saturated pad shows through the clear window as a yellow indicator, signaling that enough volume has been added and that the analytical process has been initiated. The control solution subsequently flows into an enzyme pad containing cholesterol esterase and
2
2
cholesterol oxidase which completely convert cholesterol and cholesterol esters into cholestenone and hydrogen peroxide. A flow delay pad restricts passage of the control solution to permit completion of the enzymatic reactions. Subsequently, the control solution flows into the measurement zone where colorless dyes and the enzyme peroxidase are immobilized on a thin fabric layer.
The hydrogen peroxide generated from the cholesterol in the control solution converts the colorless dyes into a blue color bar, the length of which is proportional to the amount of hydrogen peroxide, and in turn, cholesterol in the control. The bar grows until a precise amount of solution has completely filled the measurement zone and "End/Q. A." draw zone. This draw zone turns green at the end of the procedure when the cholesterol converting enzymes dissolved in the solution react with control cholesterol contained in the draw zone. The appearance of a green color signals that the test is complete and that reagents were active. The total cholesterol concentration is directly read from the factory calibrated scale on the device. Results outside the linear measurement range of the ENA·C·T™ Total Cholesterol Test cannot be reported since the printed scale on the device only covers the range between 120 and 360 mg/dL. The color formed is stable and may be read at any time within 48 hours.
The ENA·C·T™ Assayed Total Cholesterol Controls are substantially equivalent in design and intended use to other products which are used as controls in total cholesterol test systems. Most notably, it is substantially equivalent to the AccuMeter®Cholesterol Controls, manufactured for ChemTrak Incorporated, Sunnyvale, CA.