Search Results

The Hemoglobin A1c- reagent, when used in coniunction with UniCel® DxC 600/800 SYNCHRON® Systems, UniCel® DxC SYNCHRON® Systems HbA1c-Calibrators and SYNCHRON® and AU® Systems Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood.

Measurement of hemoglobin A1c measures long-term alvcemic control in patients with diabetes mellitus.

The UniCel DxC SYNCHRON Systems Hemoglobin A1c- (HbA1c-) Reagent is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. The UniCel DxC Systems utilize two unique cartridges, Hband A1c-, to determine hemoglobin A1c concentration as a ratio of total hemoqlobin.

Hb- reagent is used to measure total hemoglobin concentration by a colorimetric method. The system automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 8.6 parts reagent. The system monitors the change in absorbance at 410 nanometers. This change in absorbance is directly proportional to the concentration of total hemoglobin in the sample and is used by the system to calculate and express total hemoglobin concentration.

A1c- reagent is used to measure the hemoglobin A1c concentration by a turbidimetric immunoinhibition method. In the reaction, hemoglobin A1c antibodies combine with hemoglobin A1c from the sample to form soluble antigen-antibody complexes. Polyhaptens from the reagent then bind with the excess antibodies and the resulting agglutinated complex is measured turbidimetrically. The system automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 28 parts reagent. The system monitors the change in absorbance at 340 nanometers. This change in absorbance is inversely proportional to the concentration of hemoglobin A1c in the sample and is used by the systems to calculate and express hemoglobin A1c concentration as a ratio of total hemoglobin.

This 510(k) premarket notification describes the UniCel DxC SYNCHRON Systems Hemoglobin A1c- (HbA1c-) Reagent, which is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. The submission compares the modified device to a predicate device and presents performance study results to demonstrate substantial equivalence.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The Nova Stat Profile pHOx Ultra Analyzer with CO-Oximeter is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in heparinized whole blood; Na+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples.

The Nova Stat Profile pHOx Ultra Analyzer without CO-Oximeter is intended for in vitro diagnostic use by health care professionals and/or point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma.

The intended use of the Nova STP pHOx Ultra Calibrator Cartridge is for the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma.

The intended use of the Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in human blood using the Nova Stat Profile pHOx Ultra Analyzer System with CO-Oximeter.

Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Controls and Autocartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Stat Profile pHOx Ultra Analyzer.

As in the Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830) predicate device, the Nova Stat Profile pHOx Ultra Analyzer System combines Blood Gas/pH, Chemistry, bilirubin and CO-Oximetry testing into one Point-of-Care Analyzer. This device is analyte configurable by the end user, based on tests needed.

As with the predicate, this device is microprocessor-based and incorporates:

• traditional electrode technology to measure blood pH, pCO2, pO2 .
• Nova Biomedical proprietary optical reflectance technology for the measurement of oxygen . saturation
• ion selective electrode technology to measure blood sodium, chloride, ionized . calcium, ionized magnesium
• enzyme/amperometric technology for glucose, urea nitrogen, lactate and creatinine . measurements
• conductivity/Na+ correction for hematocrit .
• multi-wavelength reflectance/conductivity correction for hemoglobin. .

Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood qas electrodes using external compressed gas cylinders. Quality control materials are available as external ampules and as internal auto-cartridge quality control packs. Sampling, calibration and quality control are fully automated.

Nova will market the Nova Stat Profile pHOx Ultra Analyzer System in two configurations. The proposed Nova Stat Profile pHOx Ultra Analyzer System with CO-Ox module (Catalog #42013) will be offered with all the parameters listed above. A second configuration will be offered, called the Nova Stat Profile pHOx Ultra Analyzer System without the CO-Ox module (Catalog #42014). This configuration will not have the capability to measure Oxyhemoglobin (O₂Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), and Reduced Hemoglobin (HHb) or bilirubin.

This 510(k) summary (K110648) describes the Nova Stat Profile pHOx Ultra Analyzer System as substantially equivalent to the predicate device, the Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830). The submission primarily focuses on demonstrating equivalence due to component obsolescence, rather than presenting a study to prove new performance criteria.

Therefore, the acceptance criteria are implicitly those established for the predicate device, and the "study" is a comparison and verification that the changes to the Nova Stat Profile pHOx Ultra Analyzer System did not affect the performance and maintain equivalence.

Here's the information broken down based on the provided text, recognizing the nature of this 510(k) (substantial equivalence based on component updates):

1. Table of Acceptance Criteria and Reported Device Performance

(Note: Since this is a substantial equivalence claim based on component changes, explicit acceptance criteria values for each analyte are not provided in this document. Instead, the "acceptance criteria" for the new device is to perform equivalently to the predicate. The reported device performance is that it met this equivalence.)

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

The document does not explicitly state the sample size or data provenance (country of origin, retrospective/prospective) for the "performance verification testing." Given the nature of a 510(k) for component changes, this testing would typically involve a series of internal laboratory tests comparing the updated device's output to the predicate's output across a range of relevant samples (e.g., blood controls, patient samples).

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

This type of 510(k) submission, focused on component equivalence for an in vitro diagnostic device, typically relies on established reference methods or calibrated controls as the "ground truth" rather than expert consensus on individual cases. The document does not specify the use of "experts" to establish ground truth for a test set in the traditional sense of clinical imaging or diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable. This submission does not describe a process involving adjudication of test results, as it is focused on technical equivalence to a predicate device rather than human interpretation or complex diagnostic assessment.

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

Not applicable. This is an IVD device for quantitative measurements, not an AI-assisted diagnostic imaging device. An MRMC study is not relevant to this submission.

6. Standalone Performance Study

Yes, in essence, a "standalone" performance verification for the new device was implicitly conducted against the predicate device. The submission states: "The results of software validation and performance verification testing confirmed that the modifications made to the hardware and software of the Nova Stat Profile pHOx Ultra Analyzer System did not affect the safety, efficacy or performance of the system is substantially equivalent to the predicate device." This indicates that the device was tested to ensure its standalone performance matches that of the predicate.

7. Type of Ground Truth Used

The ground truth for this device would be established through a combination of:

• Traceability to Reference Methods: Calibrators and controls used for the device would be traceable to recognized reference measurement procedures or certified reference materials for each analyte.
• Comparison to Predicate Device: The primary "ground truth" in this context is the established performance of the legally marketed predicate device (Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System). The new device's performance was verified to be equivalent.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that relies on a "training set" to learn. It is a measurement device with established electrochemical and optical principles.

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

Not applicable, as there is no "training set" for this type of IVD device.

Ask a specific question about this device

ELITech Clinical Systems HbA1c is intended for use in the quantitative in vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood on Vital Scientific SelectralFlexor analyzers.It is not intended for use in Point of Care settings.

HbA1c measurements are used for the monitoring of long term blood glucose control in diabetic patients.

ELITech Clinical Systems HbA1c CALIBRATOR SET is a calibrator with 4 different levels of values for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems HbA1c on Vital Scientific Selectra/Flexor analyzers as specified in the instructions for use.

ELITech Clinical Systems HbA1c Control L+H is a quality control with.2 levels of values (Low and High values) for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems HbA1c on Vital Scientific SelectralFlexor analyzers as specified in the instructions for use.

The device for this submission is available as a kit only. It consists of 3 reagents. Reagent R1 contains suspended latex particles in a buffer with stabilizers and sodium azide. Reagent R2a and Reagent R2b are mixed to prepare a working reagent, Reagent 2. This mixture contains Mouse anti-human HbA1c monoclonal antibody and Goat anti-mouse IgG polyclonal antibody in a buffer containing stabilizers and sodium azide. Reagent R3, a hemolysis reagent, is an aqueous solution containing sodium azide.

The device for this submission is available as kit only. It consists of 4 different levels of calibrator at 0.5 mL volume. Each level consists of lyophilized hemolysates prepared from human erythrocytes. HbA1c CALIBRATOR SET is prepared exclusively from the blood of donors teste individually and found to be negative for HbsAg and to antibodies to HCV and HI according to FDA-approved methods.

ELITech Clinical Systems HbA1c Control L + H is a two level quality control products consisting of lyophilized hemolysates prepared from human erythrocytes containing constituents at desired levels. HbA1c CONTROL L+ H is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.

The provided document is a 510(k) summary for the ELITech Clinical Systems HbA1c reagent, calibrator set, and control set. It details the substantial equivalence of these devices to a predicate device, focusing on their intended use, assay principle, composition, and performance characteristics. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt (e.g., sample sizes for training/test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance).

The document is a regulatory submission for in vitro diagnostic (IVD) assays, not an AI/ML-based medical device. Therefore, many of the requested categories (e.g., test set sample size, data provenance, expert-established ground truth, adjudication method, MRMC studies, standalone performance, training set sample size, how training ground truth was established) are not applicable or typically reported in this type of submission. Performance for IVD devices is usually evaluated through analytical studies (precision, accuracy/method comparison, linearity, interference) rather than clinical studies with expert-adjudicated ground truth as seen in AI/ML device submissions.

Here's an attempt to answer based on the provided text, highlighting where information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative table for accuracy. Instead, it compares the proposed device's performance to the predicate device's performance and clinical utility. The "Conclusion" sections uniformly state that the device "met all acceptance criteria" without detailing what those criteria were. However, we can infer some performance metrics:

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The document does not explicitly state the sample size used for the method comparison (accuracy) study. It provides the regression equation and correlation coefficient (r = 0.984) derived from this study, but not the 'n' value.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). This type of detail is not typically included in a 510(k) summary for an IVD reagent. The study would have been an analytical validation study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. For an IVD assay like HbA1c, "ground truth" for individual samples is typically established by comparative methods (e.g., a reference method like HPLC or a legally marketed predicate device) rather than expert adjudication. The study is a method comparison study against the predicate device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. As this is an IVD assay comparison, not an AI/ML image-based diagnosis, expert adjudication methods are not used.

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 AI/ML device, and no MRMC study or evaluation of human reader improvement is relevant or discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a quantitative diagnostic reagent kit for an automated analyzer. Its performance is inherently "standalone" in the sense that the instrument processes the sample and the reagent measures the HbA1c level without direct human interpretive intervention beyond running the assay and interpreting the numerical result. There is no "algorithm" in the AI/ML sense to be evaluated in a standalone manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the method comparison study, the "ground truth" (or reference) for evaluation appears to be the predicate device (Pointe Scientific Hemoglobin A1c Reagent Set). The study compares the ELITech device's results (Y) against the predicate device's results (X) using regression analysis ($y=0.926x + 0.1 %$).

8. The sample size for the training set

• Not Applicable. This is an IVD diagnostic reagent, not an AI/ML algorithm that undergoes "training." The device's performance is characterized through analytical validation studies.

9. How the ground truth for the training set was established

• Not Applicable. There is no "training set" or establishment of ground truth for training in the context of this type of device.

Ask a specific question about this device

C.f.a.s. (Calibrator for automated systems) HbA1c is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

C.f.a.s. HbA1c is single-level lyophilized calibrator based on hemolyzed sheep blood and human blood. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. During use, calibrator dilutions are prepared automatically on-board the analyzer resulting in six levels.

The provided text is a 510(k) summary for a medical device called "C.f.a.s. (Calibrator for Automated Systems) HbA1c". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data as often seen for diagnostic or therapeutic devices.

Therefore, many of the requested elements for a study proving device performance are not directly available in the provided text. The summary emphasizes the similarities and differences between the new calibrator and its predicate, asserting that these differences do not raise new questions of safety or effectiveness.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document as it would be for a typical performance study. For a calibrator, "performance" is typically related to its stability, accuracy in providing a known concentration, and its ability to enable accurate measurements by the instrument it calibrates. The document asserts that the new device is substantially equivalent to a predicate calibrator.

The "acceptance criteria" for a calibrator like this would typically involve:

• Assigned value accuracy: The calibrator, once reconstituted, must have an accurate and stable assigned value for HbA1c.
• Stability: Meeting the stated stability claims (unopened, reconstituted at different temperatures and durations).
• Method compatibility: Successfully calibrating Roche clinical chemistry analyzers for Roche HbA1c methods, leading to accurate patient sample results.

The document implies these criteria are met by stating substantial equivalence to a predicate device with identical core characteristics. No quantitative performance metrics are provided in this summary.

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

This information is not provided in the document. As a 510(k) summary for a calibrator, it focuses on the device's characteristics and its equivalence to a predicate, not on a clinical trial with a "test set" of patient data.

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

This information is not applicable/not provided. The device is a calibrator, not a diagnostic tool that interprets patient data. Therefore, there's no "ground truth" for a test set of patient cases established by experts in this context. The "ground truth" for a calibrator would be its accurately assigned HbA1c concentration.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no "test set" of patient data that would require expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not applicable/not provided. This type of study is relevant for diagnostic imaging or interpretation devices where human performance is being evaluated, and is not relevant for a calibrator.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This information is not applicable/not provided. The device is a calibrator, not an algorithm.

7. The Type of Ground Truth Used

For a calibrator, the "ground truth" would be the assigned value of the analytes (HbA1c in this case) at each level of the calibrator. This value is established through highly accurate reference methods and/or traceability to international reference materials. The document implies this "ground truth" is reliably established, making the calibrator suitable for its intended purpose.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This concept applies to machine learning algorithms, not to a medical calibrator.

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

This information is not applicable/not provided.

In summary: The provided 510(k) summary for the C.f.a.s. HbA1c calibrator is a submission focused on demonstrating substantial equivalence to a predicate device. It highlights the physical, chemical, and functional similarities, and explains the differences (such as handling, levels, and stability conditions) without presenting specific, quantitative performance study data or details on "acceptance criteria" as they might apply to a diagnostic or therapeutic device. The "study" here is the comparison to the predicate device, asserting that the new device performs equivalently for its intended use as a calibrator.

Ask a specific question about this device

The CDS Hematology Calibrator for red cell, white cell and platelet counting is a device that resembles red cells, white cells and platelets in whole blood specimens and is intended to serve as a calibration standard for automated hematology analyzers, including Beckman Coulter: S-Plus IV-VI series, STKR, JS, JR, ST and JT series, STKS, MAXM, MD, Counto, OnyX, T series and A . T and A . T diff series analyzers; the Abbott Cell-Dyn 1100, Cell-Dyn 1400, 1500, 1600 and 1700 analyzers; and the Danam EXCEL 16 and EXCEL 22 and Coulter Ac T diff analyzers used to count red cells, white cells and platelets. It is a stable suspension of particles whose size, shape, concentration and other characteristics have been precisely and accurately determined.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the CDS Hematology Calibrator (CDS CAL). It states that the device is substantially equivalent to legally marketed predicate devices, meaning it can be marketed. However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about performance, sample size, ground truth, or expert qualifications.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval based on "substantial equivalence" rather than detailed performance metrics and studies.

Ask a specific question about this device

Cal-Chex CD Plus is intended to be used as a calibrator for the calibration of WBC, RBC, Hgb, MCV, PLT and MPV (MPV on CD4000 only) on the Abbott Cell-Dyn 3200 and 4000 hematology instruments.

Cal-Chex CD Plus is a suspension of stabilized human red blood cells, human white blood cells, and human platelets packaged in glass vials containing 3.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in a PVC clamshell.

The provided text describes the Cal-Chex CD Plus device, an in-vitro diagnostic calibrator for hematology instruments. Let's break down the acceptance criteria and study details based on the information provided.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria with specific thresholds (e.g., "accuracy > 95%"). Instead, the acceptance criteria are framed around performance characteristics observed in the studies, demonstrating the device's suitability as a calibrator.

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

The document does not explicitly state the sample size used for the test set in terms of the number of samples or runs. It mentions "Three studies of Cal-Chex CD Plus were conducted," but details on the number of units or measurements within these studies are not provided.

• Sample Size: Not specified quantitatively.
• Data Provenance: Not specified (e.g., country of origin). The studies were conducted by Streck Laboratories, Inc., the manufacturer. It is a retrospective analysis of internal studies.

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

This information is not provided. For a calibrator, "ground truth" would typically refer to established reference values or methods for calibration. The document states the device was compared to "whole blood calibration methods," implying these methods served as a reference, but does not detail the process or expert involvement in establishing these reference values.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where multiple experts might disagree on an interpretation, often in imaging or clinical diagnosis. For a quantitative calibrator, the assessment is based on measurements against a reference.

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

This information is not applicable and therefore not provided. MRMC studies and the concept of "human readers improve with AI" are relevant for devices involving human interpretation of data, often in the context of AI-assisted diagnostics. Cal-Chex CD Plus is a calibrator for automated hematology instruments, not a device that assists human readers in interpreting data.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This concept is not directly applicable in the same way it would be for an AI algorithm. Cal-Chex CD Plus is the device (a physical calibrator), and its performance is its "standalone" performance when used with the specified hematology instruments. The studies evaluate the performance of the calibrator itself.

7. The Type of Ground Truth Used

The ground truth used for comparison was "whole blood calibration methods." This implies using fresh patient samples calibrated through established and presumably validated laboratory procedures as the reference standard against which the performance of Cal-Chex CD Plus was assessed.

8. The Sample Size for the Training Set

This information is not provided. For a physical calibrator, the concept of a "training set" as understood in machine learning is not directly applicable. The formulation and initial testing of the product would involve extensive internal R&D, but this is not typically framed as a distinct "training set" in the context of device validation for regulatory submission.

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

This information is not applicable in the typical machine learning sense. The "ground truth" for developing the calibrator (its formulation, stability, etc.) would have been established through a combination of scientific principles, laboratory development, and comparison to existing validated calibration methods for hematology parameters.

Ask a specific question about this device