(78 days)
No
The summary describes a system that uses centrifugation and an analyzer to measure hematological parameters. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The performance studies focus on regression analysis and correlation, which are standard statistical methods, not indicative of AI/ML.
No
The device provides diagnostic information (hematology profile) and does not directly treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The QBC® AUTOREAD™ System provides a diagnostic hematology profile on venous or capillary blood."
No
The device description explicitly lists hardware components including an analyzer, power pack, printer, centrifuge, and test accessories.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system "provides a diagnostic hematology profile on venous or capillary blood." This clearly indicates that the device is intended to be used in vitro (outside the body) to diagnose or provide information for diagnosis.
- Device Description: The description details how the system uses "specially designed tubes known as the QBC® AccuTube" which are "filled with blood and centrifuged." This process of analyzing blood samples in vitro is characteristic of an IVD.
- Performance Studies: The "Summary of Performance Studies" describes accuracy and precision studies conducted using blood samples, further confirming its use in analyzing biological specimens in vitro.
The definition of an IVD is a medical device that is intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
The QBC® AUTOREAI)™ 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).
Product codes (comma separated list FDA assigned to the subject device)
Not Found
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.
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
Not Found
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)
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.
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.
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
HEMATOCRIT STUDY
CORRELATION COEFFICIENT: 0.993, SLOPE: 0.991, INTERCEPT: 0.270 (Relocated QBC AccuTube vs spun microhematocrit)
CORRELATION COEFFICIENT: 0.999, SLOPE: 0.975, INTERCEPT: 1.015 (Relocated QBC AccuTube vs original QBC AccuTube)
HEMOGLOBIN STUDY
CORRELATION COEFFICIENT: 0.995, SLOPE: 0.969, INTERCEPT: 0.410 (Relocated QBC AccuTube vs impedance system)
CORRELATION COEFFICIENT: 0.999, SLOPE: 0.981, INTERCEPT: 0.239 (Relocated QBC AccuTube vs original QBC AccuTube)
Summary of other hematological parameters
PLATELETS: CORRELATION COEFFICIENT: 0.989, SLOPE: 0.932, INTERCEPT: 11.633
WHITE BLOOD CELLS: CORRELATION COEFFICIENT: 0.984, SLOPE: 1.031, INTERCEPT: -0.116
GRANULOCYTES (#): CORRELATION COEFFICIENT: 0.985, SLOPE: 1.045, INTERCEPT: 0.002
LYMPHOCYTES/MONOCYTES (#): CORRELATION COEFFICIENT: 0.967, SLOPE: 0.921, INTERCEPT: 0.080
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
QBC® AUTOREAD™ System (K910834), QBC® AccuTube for QBC® AUTOREAD™ (K953340)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
MAY 17 1996
Becton Dickinson Primary Care Diagnostics 7 Loveton Circle Sparks, Maryland 21152-0370 Telephone (410) 316-4000
510(K) SUMMARY
-
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.
1
TABLE 1: SUMMARY OF SIMILARITIES TO AND DIFFERENCES FROM CURRENTLY MARKETED AND/OR CLEARED DEVICES
| PRODUCT NAME | |||
|---|---|---|---|
| PRODUCT | |||
| ATTRIBUTES | QBC AUTOREAD | ||
| System | |||
| K910834 | QBC AccuTube for | ||
| AUTOREAD System | |||
| K953340 | QBC AUTOREAD | ||
| System | |||
| (as configured and | |||
| presented in this | |||
| submission) | |||
| SYSTEM HARDWARE | QBC AUTOREAD | QBC AUTOREAD | QBC AUTOREAD |
| TUBE TYPES | 2 tube types: venous | ||
| and capillary | 1 tube type: QBC | ||
| AccuTube | |||
| [or] | |||
| 2 tube types: venous | |||
| and capillary | 1 tube type: QBC | ||
| AccuTube (modified) | |||
| [or] | |||
| 2 tube types: venous | |||
| and capillary | |||
| TUBE FILLING | |||
| MECHANISM FOR | |||
| VENOUS BLOOD | |||
| SAMPLES | QBC Pipetter | QBC Pipetter | QBC Pipetter |
| [or] | |||
| AccuTube filled via | |||
| capillary action | |||
| TUBE FILLING | |||
| MECHANISM FOR | |||
| CAPILLARY (FINGER | |||
| STICK) BLOOD | |||
| SAMPLES | Capillary action | Capillary action | Capillary action |
| SYSTEM | |||
| HEMATOLOGY | |||
| PARAMETERS | White Blood Cell | ||
| Granulocyte | |||
| Lymph/Mono | |||
| Platelet | |||
| Hematocrit | |||
| Hemoglobin | |||
| MCHC | White Blood Cell | ||
| Granulocyte | |||
| Lymph/Mono | |||
| Platelet | |||
| Hematocrit | |||
| Hemoglobin | |||
| MCHC | White Blood Cell | ||
| Granulocyte | |||
| Lymph/Mono | |||
| Platelet | |||
| Hematocrit | |||
| Hemoglobin | |||
| MCHC | |||
| FIBRINOGEN TESTING | |||
| CAPABILITIES | Available | Available | Available |
| BAR CODE/POSITIVE | |||
| PATIENT | |||
| IDENTIFICATION | Not available | Not available | Available for QBC |
| AccuTube | |||
| HEMATOLOGY | |||
| DIAGNOSTICS | |||
| REPORTS | Available | Available | Available |
| PRODUCT NAME | |||
| PRODUCT | |||
| ATTRIBUTES | QBC AUTOREAD | ||
| System | |||
| K910834 | QBC AccuTube for | ||
| AUTOREAD System | |||
| K953340 | QBC AUTOREAD | ||
| System | |||
| (as configured and | |||
| presented in this | |||
| submission) | |||
| OUT OF RANGE | |||
| VALUES | Values outside the | ||
| validated operating | |||
| range are shown | |||
| blinking on the | |||
| AUTOREAD display; | |||
| values are flagged as | |||
| out of range on the | |||
| sample printout | Values outside the | ||
| validated operating | |||
| range are shown | |||
| blinking on the | |||
| AUTOREAD display; | |||
| values are flagged as | |||
| out of range on the | |||
| sample printout | Values outside the | ||
| validated operating | |||
| range are shown | |||
| blinking on the | |||
| AUTOREAD display; | |||
| values are flagged as | |||
| out of range on the | |||
| sample printout | |||
| MODE | |||
| FEATURES/SELECTION | |||
| FOR CONTROL, | |||
| PROFICIENCY TEST, | |||
| CHECK ROD, AND | |||
| PATIENT SPECIMEN | |||
| TESTING | Modes manually | ||
| selected by operator | |||
| 6 modes | Modes manually | ||
| selected by operator | |||
| 5 modes | Modes manually | ||
| selected by operator | |||
| 5 modes |
2
TABLE 1 (Continued): SUMMARY ()F SIMILARITIES TO AND DIFFERENCES FROM CURRENTLY MARKETED AND/OR CLEARED DEVICES
3
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 | ||
|---|---|---|
| CORRELATION | ||
| COEFFICIENT | 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 | ||
|---|---|---|
| CORRELATION | ||
| COEFFICIENT | 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.
4
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 | ||
|---|---|---|
| CORRELATION | ||
| COEFFICIENT | 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 | ||
|---|---|---|
| CORRELATION | ||
| COEFFICIENT | 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 | CORRELATION
COEFFICIENT | SLOPE | INTERCEPT |
|-------------------------------|----------------------------|-------|-----------|
| PLATELETS | 0.989 | 0.932 | 11.633 |
| WHITE BLOOD
CELLS | 0.984 | 1.031 | -0.116 |
| GRANULOCYTES (#) | 0.985 | 1.045 | 0.002 |
| LYMPHOCYTES/
MONOCYTES (#) | 0.967 | 0.921 | 0.080 |
5
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.