(78 days)
The QBC® AUTOREAD™ System provides a diagnostic hematology profile on venous or capillary blood: hematocrit, hemoglobin, MCHC, platelet count, white blood cell count, granulocyte count (% and number), and lymphocyte/monocyte count (% and number).
The QBC® AUTOREAD™ System includes an analyzer, power pack, printer, centrifuge, and test accessories. The system uses specially designed tubes known as the QBC® AccuTube. AccuTubes are filled with blood and centrifuged. The spun tube is placed in the QBC® AUTOREAD™ analyzer which provides a report.
The provided text describes a 510(k) summary for the QBC® AUTOREAD™ System, focusing on its equivalency to a predicate device. Here's an analysis of the acceptance criteria and the supporting study, based on the information given:
Acceptance Criteria and Reported Device Performance
The core of the acceptance criteria for this 510(k) submission is demonstrating equivalency to the predicate device and established methods for hematology parameters. The "reported device performance" is essentially the statistical measures (correlation coefficient, slope, intercept) derived from the equivalency studies.
| Parameter | Acceptance Criteria (Implicit: Strong Correlation and Slope ~1, Intercept ~0 when compared to predicate/reference) | Reported Device Performance (Correlation Coefficient, Slope, Intercept) - Against Reference or Predicate |
|---|---|---|
| Hematocrit | Equivalent to spun microhematocrit method | Against Spun Microhematocrit:Correlation Coefficient: 0.993Slope: 0.991Intercept: 0.270 |
| Equivalent to original QBC AccuTube/AUTOREAD System | Against Original QBC AccuTube/AUTOREAD:Correlation Coefficient: 0.999Slope: 0.975Intercept: 1.015 | |
| Hemoglobin | Equivalent to impedance cell counter method | Against Impedance System:Correlation Coefficient: 0.995Slope: 0.969Intercept: 0.410 |
| Equivalent to original QBC AccuTube/AUTOREAD System | Against Original QBC AccuTube/AUTOREAD:Correlation Coefficient: 0.999Slope: 0.981Intercept: 0.239 | |
| Platelets | Equivalent to original QBC AccuTube/AUTOREAD System | Against Original QBC AccuTube/AUTOREAD:Correlation Coefficient: 0.989Slope: 0.932Intercept: 11.633 |
| White Blood Cells | Equivalent to original QBC AccuTube/AUTOREAD System | Against Original QBC AccuTube/AUTOREAD:Correlation Coefficient: 0.984Slope: 1.031Intercept: -0.116 |
| Granulocytes (#) | Equivalent to original QBC AccuTube/AUTOREAD System | Against Original QBC AccuTube/AUTOREAD:Correlation Coefficient: 0.985Slope: 1.045Intercept: 0.002 |
| Lymphocytes/Monocytes (#) | Equivalent to original QBC AccuTube/AUTOREAD System | Against Original QBC AccuTube/AUTOREAD:Correlation Coefficient: 0.967Slope: 0.921Intercept: 0.080 |
Study Details
Regarding the study that proves the device meets the acceptance criteria:
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Sample size used for the test set and the data provenance:
- Hematocrit and Hemoglobin equivalency study: 160 fresh EDTA whole blood samples.
- Data Provenance: The study was conducted at "two hospital sites". No specific country of origin is mentioned, but the company address is in Sparks, Maryland, USA, suggesting the data is likely from the United States. The samples were "fresh EDTA whole blood samples," indicating they were retrospectively collected from patients.
- Other Parameters (Platelets, WBC, Granulocytes, Lymphocytes/Monocytes): The sample size for these parameters is not explicitly stated, but it's implied to be the same set of samples or a comparable set used for the hematocrit and hemoglobin equivalency against the original QBC AccuTube.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of device (automated differential cell counter) does not typically rely on human expert consensus for "ground truth" in the same way as image-based diagnostics. The ground truth here is established by reference methods (e.g., spun microhematocrit method, impedance cell counter, or the established predicate device).
- Therefore, the concept of "number of experts" and "qualifications" doesn't directly apply here for establishing the ground truth, as it's a quantitative measurement device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is mentioned or relevant for this type of quantitative device study. Measurements are taken and compared directly to reference methods.
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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:
- No. This is not an MRMC comparative effectiveness study. It is a study to demonstrate the analytical equivalency of a diagnostic device to predicate devices and established reference methods. Human reader performance or AI assistance are not relevant to this type of submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The "device" in question is an automated system (QBC® AUTOREAD™ System) which includes an analyzer and algorithms to generate results. The studies described evaluate the performance of this system (including its modified algorithm) in a standalone capacity against reference methods and the predicate device. There is no human interpretation component being evaluated in these specific studies; it's the machine's output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Reference Methods:
- For Hematocrit: Spun microhematocrit method.
- For Hemoglobin: Impedance cell counter method.
- For all parameters (Hematocrit, Hemoglobin, Platelets, White Blood Cells, Granulocytes, Lymphocytes/Monocytes): The original QBC AccuTube read with the original QBC AUTOREAD algorithm (the predicate device).
- Reference Methods:
-
The sample size for the training set:
- The document does not explicitly mention a separate "training set" or its size. Since this is a 510(k) summary for a device with modified components (AccuTube and algorithms), the modifications were likely developed and refined using internal data, but the submission focuses on the validation or test data to demonstrate equivalency. It is possible that the algorithm adjustments were "trained" on some data, but this information is not provided in the summary.
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How the ground truth for the training set was established:
- Given the lack of information on a "training set," there's no detail on how ground truth for such a set would have been established. However, for internal development, it would typically involve comparing preliminary device results against similar reference methods as used in the validation studies.
Conclusion: The studies described successfully demonstrate the equivalency of the modified QBC® AUTOREAD™ System to established reference methods and its predicate device for the measured hematology parameters, addressing the implicit acceptance criteria for this 510(k) submission.
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MAY 17 1996
Becton Dickinson Primary Care Diagnostics 7 Loveton Circle Sparks, Maryland 21152-0370 Telephone (410) 316-4000
510(K) SUMMARY
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SUBMITTED BY: BECTON DICKINSON PRIMARY CARE DIAGNOSTICS BECTON DICKINSON AND COMPANY 7 LOVETON CIRCLE SPARKS, MD 21152
CONTACT: Rocky Ganske, Director of Quality Management and Regulatory Compliance -
TELEPHONE: (410) 316-4713
PREPARED: February 21, 1996
TRADE NAME: QBC® AUTOREAD™ System
COMMON NAME: Automated Differential Cell Counter
CLASSIFICATION NAME:
Automated Differential Cell Counter
- QBC® AUTOREAD™ System (K910834) PREDICATE DEVICE: QBC® AccuTube for QBC® AUTOREAD™ (K953340)
- The QBC® AUTOREAI)™ System provides a diagnostic hematology INTENDED USE: profile on venous or capillary blood: hematocrit, hemoglobin, MCHC, platelet count, white blood cell count, granulocyte count (% and number), and lymphocyte/monocyte count (% and number).
- DEVICE DESCRIPTION: The QBC® AUTOREAD™ System includes an analyzer, power pack, printer, centrifuge, and test accessories. The system uses specially designed tubes known as the QBC® AccuTube. AccuTubes are filled with blood and centrifuged. The spun tube is placed in the QBC® AUTOREAD™ analyzer which provides a report.
DEVICE TECHNOLOGICAL CHARACTERISTICS:
Tables 1 summarizes the similarities to and differences from currently marketed and/or cleared devices.
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TABLE 1: SUMMARY OF SIMILARITIES TO AND DIFFERENCES FROM CURRENTLY MARKETED AND/OR CLEARED DEVICES
| PRODUCT NAME | |||
|---|---|---|---|
| PRODUCTATTRIBUTES | QBC AUTOREADSystemK910834 | QBC AccuTube forAUTOREAD SystemK953340 | QBC AUTOREADSystem(as configured andpresented in thissubmission) |
| SYSTEM HARDWARE | QBC AUTOREAD | QBC AUTOREAD | QBC AUTOREAD |
| TUBE TYPES | 2 tube types: venousand capillary | 1 tube type: QBCAccuTube[or]2 tube types: venousand capillary | 1 tube type: QBCAccuTube (modified)[or]2 tube types: venousand capillary |
| TUBE FILLINGMECHANISM FORVENOUS BLOODSAMPLES | QBC Pipetter | QBC Pipetter | QBC Pipetter[or]AccuTube filled viacapillary action |
| TUBE FILLINGMECHANISM FORCAPILLARY (FINGERSTICK) BLOODSAMPLES | Capillary action | Capillary action | Capillary action |
| SYSTEMHEMATOLOGYPARAMETERS | White Blood CellGranulocyteLymph/MonoPlateletHematocritHemoglobinMCHC | White Blood CellGranulocyteLymph/MonoPlateletHematocritHemoglobinMCHC | White Blood CellGranulocyteLymph/MonoPlateletHematocritHemoglobinMCHC |
| FIBRINOGEN TESTINGCAPABILITIES | Available | Available | Available |
| BAR CODE/POSITIVEPATIENTIDENTIFICATION | Not available | Not available | Available for QBCAccuTube |
| HEMATOLOGYDIAGNOSTICSREPORTS | Available | Available | Available |
| PRODUCT NAME | |||
| PRODUCTATTRIBUTES | QBC AUTOREADSystemK910834 | QBC AccuTube forAUTOREAD SystemK953340 | QBC AUTOREADSystem(as configured andpresented in thissubmission) |
| OUT OF RANGEVALUES | Values outside thevalidated operatingrange are shownblinking on theAUTOREAD display;values are flagged asout of range on thesample printout | Values outside thevalidated operatingrange are shownblinking on theAUTOREAD display;values are flagged asout of range on thesample printout | Values outside thevalidated operatingrange are shownblinking on theAUTOREAD display;values are flagged asout of range on thesample printout |
| MODEFEATURES/SELECTIONFOR CONTROL,PROFICIENCY TEST,CHECK ROD, ANDPATIENT SPECIMENTESTING | Modes manuallyselected by operator6 modes | Modes manuallyselected by operator5 modes | Modes manuallyselected by operator5 modes |
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TABLE 1 (Continued): SUMMARY ()F SIMILARITIES TO AND DIFFERENCES FROM CURRENTLY MARKETED AND/OR CLEARED DEVICES
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SUMMARY OF DEVICE TESTING:
ACCURACY STUDIES
Accuracy data for the OBC AUTOREAD System is derived from K953340; performance of the OBC AUTOREAD System with the modified QBC AccuTube disposable is equivalent to that of the QBC AUTOREAD System with the original OBC AccuTube disposable. The hardware utilized by both systems to read the AccuTube is identical. The disposable is identical with the exception of movement of the reagent coating to facilitate filling of the AccuTube via capillary action and incorporation of a fluorescent stripe on the outside of the tube for positive tube type identification, Calculation algorithms are identical with the exceptior of adjustments made to the hematocrit and hemoglobin algorithms to compensate for movement of the reagent coating within the AccuTube.
A study was performed to demonstrate equivalency between the relocated reagent coating AccuTube/AUTOREAD System and the original AccuTube/AUTOREAD System in terms of hematocrit and hemoglobin values. The study was conducted at two hospital sites with a total of 160 fresh EDTA whole blood samples. Each sample was prepared in duplicate QBC AccuTubes with relocated reagent coating, duplicate QBC AccuTubes with original reagent coating location and duplicate microhematocrit tubes. A scatter plot comparing the relocated OBC AccuTube read with the modified QBC AUTOREAD algorithm and the spun microhematocrit method was performed. Regression statistics are summarized below:
| HEMATOCRIT STUDY | ||
|---|---|---|
| CORRELATIONCOEFFICIENT | SLOPE | INTERCEPT |
| 0.993 | 0.991 | 0.270 |
An additional scatter plot comparing the relocated QBC AccuTube read with the modified OBC AUTOREAD algorithm and the original QBC AccuTube read with the original QBC AUTOREAD algorithm was performed. Regression statistics are summarized below:
| HEMATOCRIT STUDY | ||
|---|---|---|
| CORRELATIONCOEFFICIENT | SLOPE | INTERCEPT |
| 0.999 | 0.975 | 1.015 |
This study demonstrates that QBC AccuTubes with relocated reagent coating read with a QBC AUTOREAD System provide equivalent results when compared to the spun microhematocrit method and to the original QBC AccuTube read with the original QBC AUTOREAD algorithm.
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Impedance values for hemoglobin were collected from the hospitals and compared to QBC AccuTubes and non-relocated QBC AccuTubes. A scatter plot comparing the relocated QBC AccuTube read with the modified QBC AUTOREAD System data and the impedance system data was performed. Regression statistics are summarized below:
| HEMOGLOBIN STUDY | ||
|---|---|---|
| CORRELATIONCOEFFICIENT | SLOPE | INTERCEPT |
| 0.995 | 0.969 | 0.410 |
An additional scatter plot comparing the relocated QBC AccuTube read with the modified QBC AUTOREAD algorithm and the original QBC AccuTube read with the original QBC AUTOREAD algorithm was performed. Regression statistics are summarized below:
| HEMOGLOBIN STUDY | ||
|---|---|---|
| CORRELATIONCOEFFICIENT | SLOPE | INTERCEPT |
| 0.999 | 0.981 | 0.239 |
These studies demonstrate that QBC AccuTubes with relocated reagent coating read with a QBC AUTOREAD System provide equivalent results when compared to the impedance cell counter method and to the original QBC AccuTube read with the original QBC AUTOREAD algorithm.
Scatter plots were prepared for all other hematological parameters comparing the relocated QBC AccuTube read with the modified QBC AUTOREAD algorithm and the original QBC AccuTube read with the original QBC AUTOREAD algorithm. Regression statistics are summarized below:
| PARAMETER | CORRELATIONCOEFFICIENT | SLOPE | INTERCEPT |
|---|---|---|---|
| PLATELETS | 0.989 | 0.932 | 11.633 |
| WHITE BLOODCELLS | 0.984 | 1.031 | -0.116 |
| GRANULOCYTES (#) | 0.985 | 1.045 | 0.002 |
| LYMPHOCYTES/MONOCYTES (#) | 0.967 | 0.921 | 0.080 |
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PRECISION STUDY
Accuracy data for the QBC AUTOREAD System is derived from K953340; performance of the QBC AUTOREAD System with the modified QBC AccuTube disposable is equivalent to that of the QBC AUTOREAD System with the original QBC AccuTube disposable.
CONCLUSION:
Evaluation of the QBC® AUTOREAD™ System has demonstrated its equivalency to the predicate device in terms of accuracy and precision.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”