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MCC™ URICHECK™ from HEMATRONIX, INC. is a synthetic matrix based assayed liquid urine multi-constituent control intended to monitor the precision and accuracy of instrument used in the clinical laboratory environment. MCC™ URICHECK™ is intended to monitor the precision and accuracy of instrument used in the methods when run as a patient sample and is ready to use. Expected ranges for the chemical and physical properties of MCC™ URICHECK™ have been established for monitoring or quantitative "constituents" used in routine clinical chemistry analysis.

MCC™ URICHECK™ Assayed Liquid Urine Multi-Constituent Control is a synthetic matrix based assayed liquid urine multi-constituent control.

This document pertains to a 510(k) premarket notification for a medical device called the "MCC™ URICHECK™ Assayed Liquid Urine Multi-constituent Control." It is a regulatory letter from the FDA, and as such, it does not contain the acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "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 to devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the device has been cleared based on demonstrating substantial equivalence to a predicate device, rather than through a new clinical effectiveness study demonstrating specific performance against acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth details from this document.

The document only provides:

• Device Name: MCC™ URICHECK™ Assayed Liquid Urine Multi-constituent Control
• Intended Use: To monitor the precision and accuracy of instruments used in methods for chemistry analysis in a clinical laboratory environment by being run as a patient sample.

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Retic-Quinox is a whole blood reference control material designed to monitor the accuracy and precision of Coulter instruments equipped with reticulocye measuring capabilities using VCS technology.

Retic-Quinox is a reference control material designed to monitor the accuracy and precision of Coulter instruments capable of performing reticulocyte counts.

The provided text describes a 510(k) summary for the "Retic-Quinox Reticulocyte Control Mixture," a quality control device. However, the document does not contain explicit details about acceptance criteria, a specific study proving the device meets those criteria, or the methodology (sample size, expert qualifications, ground truth establishment, etc.) of such a study.

The document primarily focuses on:

• Device Description: Retic-Quinox is a reference control material for monitoring accuracy and precision of Coulter instruments performing reticulocyte counts.
• Predicate Device Comparison: It states that both Retic-Quinox and the predicate device (Retic-C) are in vitro diagnostic controls made of stabilized human red cells and a reticulocyte-like component in a buffered fluid. Both provide three levels for monitoring.
• Substantial Equivalence: The FDA's letter states that the device is "substantially equivalent" to legally marketed predicate devices, implying it has similar performance characteristics for its intended general use as a quality control.

Therefore, based solely on the provided text, the specific information requested in your prompt regarding acceptance criteria, a standalone study, and its detailed methodology cannot be extracted. The document confirms the device's regulatory classification and its substantial equivalence determination but does not include the detailed performance study report you've asked for.

If this information were available in a more comprehensive submission or study report, it would typically include a section detailing performance data against predefined acceptance criteria.

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The Hematronix qUAntify™ Control System is a liquid, ready-to-use, urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals. Controls evaluate the quality of day-to-day test performance. The qUAntify Control System is used to determine accuracy and precision in the measurement of the physical and chemical tests commonly employed in semiquantitative urine dipstick testing. Alternative tests such as the Glucose (Clinites), Bilirubin (Ictotest) and Ketone (Acetest) are also assayed. This control can be used to quality control the specified urine hCG tests. Two distinct levels are included to verify the recovery of normal and elevated patient values.

The Hematronix qUAntify™ Control System is a liquid, ready-to-use, urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals.

This document describes the qUAntify™ Control System, a liquid, ready-to-use urine dipstick control. It is intended to determine accuracy and precision in the measurement of physical and chemical tests commonly employed in semiquantitative urine dipstick testing.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the qUAntify™ device are established by demonstrating substantial equivalence to the predicate device, Kenlor Liquid Urine Control. The performance is deemed acceptable if the observed ranges for various analytes fall within the published ranges of the predicate device.

Note: The table shows that while most qUAntify ranges align well with or encompass the Kenlor ranges, there are some differences. For instance, qUAntify's Specific Gravity for Level I is higher, pH for Level I is higher, Glucose for Level II has a wider upper range, Leukocytes is "++" for qUAntify vs. "+" for Kenlor, Urobilinogen has a wider range for qUAntify, and Bilirubin is "++" for qUAntify vs. "+++" for Kenlor. The document states that the ranges were "substantially equivalent," implying these differences were considered acceptable for equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document states that "qUAntify was evaluated on several instruments for all 11 analytes." However, it does not specify an exact sample size (e.g., number of batches, number of individual tests performed).
• Data Provenance: The document does not explicitly state the country of origin for the data. Given the address provided for Hematronix, Inc. is in California, USA, it is highly probable the testing was conducted in the USA. The study appears to be retrospective in the sense that the qUAntify data was collected and then compared against the published package insert data of the predicate device, which would also be retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• The ground truth for this device (urine control) is based on pre-established acceptable ranges of analyte concentrations, which are then used to verify the performance of a new control material.
• The document does not mention the direct involvement of experts in establishing the ground truth for this specific study. Instead, it relied on the published ranges from the predicate device's package inserts.
• Therefore, there is no information provided on the number or qualifications of experts directly involved in establishing the ground truth for this test set; rather, it leveraged existing, published standards from a comparator product.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the traditional sense (e.g., 2+1 physician review). The evaluation was a direct comparison of the instrument's readings of the qUAntify control against the pre-defined accepted ranges of the predicate device. If readings fell within the expected range, they were considered acceptable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. This type of study typically evaluates human performance with and without AI assistance, which is not applicable to a quality control material like qUAntify.

6. Standalone Performance Study

Yes, a standalone performance study was done for the qUAntify device. The document explicitly states: "qUAntify was evaluated on several instruments for all 11 analytes. The ranges observed were compared to published analytes. analy of the same analytes in package inserts provided with Kenlor's Liquid Urine Control." This describes the device (control material) being tested independently to determine its performance characteristics.

7. Type of Ground Truth Used

The type of ground truth used was predicate device performance data. Specifically, the published ranges for the 11 analytes in the package inserts of Kenlor's Liquid Urine Control served as the ground truth or "acceptance criteria" against which qUAntify's observed performance was compared.

8. Sample Size for the Training Set

The document is for a urine dipstick control material, not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The control material itself is the "device," and its composition is predetermined, not "trained."

9. How the Ground Truth for the Training Set Was Established

As stated in point 8, the concept of a training set is not applicable to this device. For the control material itself, its "ground truth" (i.e., its expected analyte concentrations and ranges) would have been established during its manufacturing and characterization process, likely through analytical chemistry methods and repeated testing to ensure consistency and assign values. However, the document does not detail this internal process for qUAntify.

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