(193 days)
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No
The device description and performance studies focus on electrical impedance measurement and comparison to a predicate device, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is for "Platelet Function testing" and measures platelet aggregation, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states "For Platelet Function testing of Whole Blood specimens using Impedance Aggregometry," which directly indicates it is used for diagnostic purposes (assessing platelet function). The "Device Description" also explains how it measures changes in impedance to determine platelet aggregation, a key diagnostic parameter.
No
The device description clearly outlines a physical instrument (Chrono-log WBA, Model 591A/592A) that uses electrical impedance and disposable electrodes to measure platelet aggregation. This involves hardware components and physical interaction with a blood sample, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For Platelet Function testing of Whole Blood specimens". This indicates the device is used to perform tests on biological samples (whole blood) outside of the body (in vitro) to provide information about a patient's health (platelet function).
- Device Description: The description details how the device measures platelet aggregation in a whole blood sample using electrical impedance. This process involves analyzing a biological specimen.
- Performance Studies: The performance studies describe testing the device with whole blood samples from human subjects (normal, healthy, drug free subjects, and patients with von Willebrands Disease). The results are expressed as aggregation in ohms, which is a measurement derived from the analysis of the biological sample.
- Predicate Device: The predicate device is also an "Aggregometer", which is a type of instrument used for in vitro diagnostic testing of platelet function.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Chrono-log WBA, Model 591A/592A is intended for determination of platelet function in a whole blood specimen, using ADP, Collagen and Ristocetin reagents.
For Platelet Function testing of Whole Blood specimens using Impedance Aggregometry. For Prescription Use.
Product codes (comma separated list FDA assigned to the subject device)
JOZ
Device Description
The Chrono-log WBA, Model 591A/592A uses electrical impedance to measure platelet aggregation in a whole blood sample. The Impedance is measured using a Disposable electrode with two precious metal pins. A small voltage is applies across these two pins. When the electrode is placed into a diluted whole blood specimen and a monolayer is formed around the two pins. In the absence of an agonist, the platelet build-up stabilizes and a baseline is established. When an agonist is added to the specimen, the platelets begin to aggregate and collect on the electrode pins causing a change in impedance. The change of impedance is directly proportional to the amount of Aggregation in the specimen. This change of impedance is displayed on a front panel readout. The instrument has an analog output which produces an aggregation curve when connected to a strip chart recorder or AGGRO/LINK interface. Model 591 A is a single channel version; Model 592A is the duel channel version.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The Chrono-log WBA Model 591A/592A was compared to the Chrono-log Whole Blood Aggregometer Model 591/592 using normal, healthy, drug free subjects. The samples were tested using Chrono-log Collagen, ADP, and Ristocetin Reagents. The following concentrations of reagents were run: Collagen 2ug/mL and 5ug/mL, ADP 1uM and 20uM and 1.0 mM; Ristocetin 0.15mg/mL, 0.15mg/mL and 1.0mg/mL. In all over 300 test were run on each type of electrodes. Normal donors (N=12) and vWD patients (N=8) were tested with Ristocetin at various concentrations. Platelet count studies were performed on Whole Blood and PRP samples.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance study compared the Chrono-log WBA Model 591A/592A (with disposable electrodes) to the Chrono-log Whole Blood Aggregometer Model 591/592 (with reusable electrodes).
Type: Comparability Study
Sample Size: Over 300 tests run on each type of electrode.
Key Results:
- Correlation between Disposable and Re-usable Electrodes: Pearson Correlation R = 0.84, Paired t test P 5Ω
These ranges were deemed close to the previously established ranges for the predicate device. - Bland-Altman Comparison: Performed for 2 ug/mL Collagen, 5 ug/mL Collagen, and 20uM ADP, showing a wide range for the 2SD cut-off, but deemed consistent with historical observations for platelet aggregation in whole blood on normal subjects.
Conclusion: The tests indicated that the two models provide comparable results and raised no new safety or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Pearson Correlation (R): 0.84
- Paired t test (P):
§ 864.5700 Automated platelet aggregation system.
(a)
Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.(b)
Classification. Class II (performance standards).
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11. 510(k) Summary
Device: Chrono-log Whole Blood Aggregometer (WBA), Model 591A/592A
Date: September 5, 2003
Submitted by: Chrono-log Corp., 2 West Park Rd., Havertown, PA 19083
Contact: Nicholas J. Veriabo (610) 853-1130
Name of Device:
Trade/Proprietary Name - Chrono-log Whole Blood Aggregometer (WBA), Model 591 A/592 A Common/Usual Name - Chrono-log Whole Blood Aggregometer Classification Name - System, Automatic Platelet Aggregation
After examining the tests data included in this application, we have found the Chrono-log Whole Blood Aggregometer with Disposable Electrodes (WBA), Model 591A/592A to be substantially equivalent to Chrono-log Whole Blood Aggregometer ( WBA) Model 591/592 (K962426).
11.1 Device Description:
The Chrono-log WBA, Model 591A/592A uses electrical impedance to measure platelet aggregation in a whole blood sample. The Impedance is measured using a Disposable electrode with two precious metal pins. A small voltage is applies across these two pins. When the electrode is placed into a diluted whole blood specimen and a monolayer is formed around the two pins. In the absence of an agonist, the platelet build-up stabilizes and a baseline is established. When an agonist is added to the specimen, the platelets begin to aggregate and collect on the electrode pins causing a change in impedance. The change of impedance is directly proportional to the amount of Aggregation in the specimen. This change of impedance is displayed on a front panel readout. The instrument has an analog output which produces an aggregation curve when connected to a strip chart recorder or AGGRO/LINK interface. Model 591 A is a single channel version; Model 592A is the duel channel version.
11.2 Intended Use:
The Chrono-log WBA, Model 591A/592A is intended for determination of platelet function in a whole blood specimen, using ADP, Collagen and Ristocetin reagents.
11.3 Technical Description:
The Chrono-log Whole Blood Aggregometer with Disposable Electrodes (WBA), Model 591 A/592A is the same device as the predicated device the Chrono-log Whole Blood Aggregometer ( WBA) Model 591/592. Both devices use Impedance method of platelet
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aggregation detection as described in Device Description. Both Devices have the same chassis design, automatic baseline setting, and front panel digital readout and the use the same internal circuit boards. The only new feature of the Model 591 A/592A is the Disposable Electrode.
11.4 Performance:
The performance of the Chrono-log WBA Model 591A/592A was compared to the Chrono-log Whole Blood Aggregometer Model 591/592 using normal, healthy, drug free subjects. The samples were tested using Chrono-log Collagen, ADP, and Ristocetin Reagents. The following concentrations of reagents were run: Collagen 2ug/mL and 5ug/mL, ADP 1uM and 20uM and 1.0 mM; Ristocetin 0.15mg/mL, 0.15mg/mL and 1.0mg/mL. In all over 300 test were run on each type of electrodes. However, due to the fact that the Disposable Electrodes were sensitive to the high dose of Ristocetin, this reagent was eliminated from these calculations and are addressed separately. The results are expressed as aggregation in ohms obtained with the concentrations of agonist stated previously.
Table 11-1 shows the correlation between the Disposable and re-usable electrodes:
TABLE 11-1
| No. of Samples | Pearson Correlation | Paired t test |
|---|---|---|
| 250 | R = 0.84 | P 5 Ω) with the normal patients and reduced (5Ω |
The previously established normal ranges for the Model 591/592 are as follows:
| Collagen | 5 µg/mL | 16-29 |
|---|---|---|
| ADP | 10 µM | 9-14 |
| Ristocetin | 1 mg/mL | 17-38 |
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Although the two sets of normal ranges are not exact, the normals are close to the previously established normal range in both value and range.
We analyzed the results of the two methods using the Bland-Altman comparison plot using reagent concentrations of 2 ug/mL Collagen, 5 ug/mL Collagen and 20uM ADP. Figures 11.6, 11.7 and 11.8 are the plot difference in ohms and the plot difference in percent for the three reagent concentrations.
Image /page/7/Figure/2 description: The image shows two Bland & Altman plots for 2 ug/mL Collagen. The left plot compares results in Ohms, while the right plot compares results in Percent. In the left plot, the mean is -0.3, and the +1.96 SD and -1.96 SD are 6.1 and -6.8, respectively. In the right plot, the mean is -3.8, and the +1.96 SD and -1.96 SD are 43.8 and -51.5, respectively.
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Image /page/8/Figure/0 description: The image shows two Bland & Altman plots for 5 ug/mL Collagen. The left plot compares the result in Ohms, while the right plot compares the result in Percent. The left plot shows the average of RP and DP on the x-axis and RP-DP on the y-axis, with a mean of 1.1 and a +1.96 SD of 8.0 and a -1.96 SD of -5.8. The right plot shows the average of RP and DP on the x-axis and (RP-DP)/Average % on the y-axis, with a mean of 5.9 and a +1.96 SD of 46.4 and a -1.96 SD of -34.6.
FIGURE 11.7
Image /page/8/Figure/2 description: The image shows two Bland & Altman plots for 20uM ADP. The plot on the left compares the results in Ohms, while the plot on the right compares the results in percent. The left plot shows the mean at -3.2, +1.96 SD at 2.0, and -1.96 SD at -8.3. The right plot shows the mean at -30.8, +1.96 SD at 31.3, and -1.96 SD at -92.9.
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Examining the graphs, we see that there is a wide range for the 2SD cut-off; however, this is not beyond what is historically seen with platelet aggregation in whole blood on normal subjects. Since these donors are all normal subjects, we are able to establish a normal range from the data. As stated previously in this report, the normal range is close in value and range to the normal range established for the Model 591/592.
The results of these tests indicate that the two models of Whole Blood Aggregometer give comparable results and raise no new issues of safety or effectiveness.
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Public Health Service
Image /page/10/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 2 2004
Mr. Nicholas J. Verabo Executive Director Chrono-Log Corp. 2 West Park Rd. Havertown, PA 19083
K032951 Re:
Trade/Device Name: Chrono-Log Whole Blood Aggregometer (WBA) Model 591A/592A Regulation Number: 21 CFR 864.5700 Regulation Name: Automated platelet aggregation system Regulatory Class: Class II Product Code: JOZ Dated: February 10, 2004 Received: February 11, 2004
Dear Mr. Verabo
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Joseph L. Aralett
Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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6. INDICATIONS FOR USE
Chrono-log Whole Blood Aggregometer (WBA) Device Name: Model 591A/592A
For Platelet Function testing of Whole Indications for Use: Blood specimens using Impedance Aggregometry.
For Prescription Use✓
Souphim Busteri
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032951