(252 days)
No
The description explicitly states the computer interface is for data collection only and has no control or input into the device. There is no mention of AI/ML in the device description, performance studies, or key metrics.
No
The device is for in-vitro diagnostic use, measuring platelet function on patient samples, which classifies it as a diagnostic device, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states, "For in-vitro diagnostic use for measuring platelet aggregation and ATP secretion in whole blood or platelet rich plasma." Additionally, the "Device Description" mentions its use in the Ristocetin Cofactor Assay "which is used to diagnose patients with von Willebrands disease." These statements confirm its diagnostic purpose.
No
The device description clearly states that the Model 700 Aggregometer is an instrument that measures platelet function using electrical impedance or optical density and can also measure ATP release using luminescence. It is a physical piece of hardware that comes with reagents and supplies. While software is provided for data collection, the core device is a hardware instrument.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first line explicitly states "For in-vitro diagnostic use".
- Device Description: The description details how the device measures platelet function on "patient samples" and is used to "diagnose patients with von Willebrands disease". These are clear diagnostic applications.
- Input Imaging Modality: While not traditional imaging, the device uses methods (optical density, electrical impedance, luminescence) to analyze biological samples (whole blood, plasma) in vitro.
- Intended User/Care Setting: The intended user is a "Laboratory", which is a typical setting for IVD devices.
- Performance Studies: The performance studies involve testing "patient samples" and comparing the device's performance to predicate devices used for diagnostic purposes.
All of these points strongly indicate that this device is intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in-vitro diagnostic use for measuring platelet aggregation and ATP secretion in whole blood or platelet rich plasma.
Product codes (comma separated list FDA assigned to the subject device)
JOZ
Device Description
The Chrono-log Model 700 Aggregometer measures platelet function on patient samples using electrical impedance in whole blood or optical density in plasma. The Model 700 Aggregometer has the capability to simultaneously measure ATP release with either method using luminescence. The Model 700 Aggregometer is also used to run the Ristocetin Cofactor Assay which is used to diagnose patients with von Willebrands disease. The instrument comes with a starter kit consisting of the following Chrono-log reagents and supplies: ADP, Arachondic Acid, Collagen, Epinephrine, Ristocetin, Thrombin, a CHRONO-LUME® Kit, a Ristocetin Cofactor Kit, cuvettes, stir bars and pipettes. The output of the Model 700 can be connected to either a strip chart recorder or to a Computer. Software is provided the computer interface option. The computer interface option is used to collect data only. The computer is not used for diagnosis or treatment and does not have any control over or input into the Model 700 Aggregometer.
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)
Comparison studies were run to compare the performance of the Model 700 to the Model 560 and the Model 591A for the disposable electrodes. Whole blood and Platelet Rich Plasma samples from normal, healthy, drug free subjects were tested with both instruments. The samples were tested using Chrono-log Collagen, ADP, Ristocetin, Epinephrine, Arachidonic Acid and Thrombin Reagents. The simultaneous measurement of ATP release was also measured using the luminescence technique. For ATP measurement CHRONO-LUME® was added to the sample.
The following concentrations of reagents were run: Collagen 2ug/mL and Spg/mL, ADP 5uM and 10uM, Arachidonic Acid 0.5 mM, Epinephrine SuM in PRP aggregation only, Ristocetin 1.0mg/mL for Whole Blood Aggregation and 1.25 mg/mL for PRP Aggregation and Thrombin for Luminescence measurement.
In Platelet Rich Plasma there were 149 comparison tests using optical aggregation with 167 Luminescence tests. In Whole Blood there were 267 comparison tests with Impedance Aggregation with 300 Luminescence tests. Although Aggregation and Luminescence are run simultaneously, there are always more Luminescence tests, because Aggregation is not measured with the thrombin reagent. At the recommended concentration, thrombin causes the platelets to clump in a single mass, which does not provide useful aggregation information. Thrombin at 1 unit concentration is used to measure the total amount of ATP in the platelets by Luminescence.
Results in Tables:
Optical Aggregation in PRP: No. of Samples = 149, Pearson correlation coefficient = 0.8204, P-value =
§ 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).
0
OCT 1 4 2005
11. 510(k) Summary
Device: Model 700 - Chrono-log Whole Blood Lumi-Aggregometer
Date: February 3, 2005
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 - Model 700 Chrono-log Whole Blood Lumi-Aggregometer
Common/Usual Name - Chrono-log Whole Blood Lumi-Aggregometer
Classification Name - System, Automatic Platelet Aggregation
After examining the test data included in this application, we have found the Chrono-log Model 700 Whole Blood Lumi-Aggregometer to be substantially equivalent to Chrono-log Model 560 Whole Blood Lumi-Aggregometer (K830749) with AGGRO/LINK Interface (K851025).
11.1 Device Description:
The Chrono-log Model 700 Aggregometer measures platelet function on patient samples using electrical impedance in whole blood or optical density in plasma. The Model 700 Aggregometer has the capability to simultaneously measure ATP release with either method using luminescence. The Model 700 Aggregometer is also used to run the Ristocetin Cofactor Assay which is used to diagnose patients with von Willebrands disease. The instrument comes with a starter kit consisting of the following Chrono-log reagents and supplies: ADP, Arachondic Acid, Collagen, Epinephrine, Ristocetin, Thrombin, a CHRONO-LUME® Kit, a Ristocetin Cofactor Kit, cuvettes, stir bars and pipettes. The output of the Model 700 can be connected to either a strip chart recorder or to a Computer. Software is provided the computer interface option. The computer interface option is used to collect data only. The computer is not used for diagnosis or treatment and does not have any control over or input into the Model 700 Aggregometer.
1
11.2 Intended Use:
For in-vitro diagnostic use for measuring platelet aggregation and ATP secretion in whole blood or platelet rich plasma.
11.3 Technical Description:
The Chrono-log Model 700 Aggregometer is an Instrument used in the Laboratory for the determination of Platelet Aggregation in samples of either PRP or whole blood specimens with simultaneous measurement of ATP release. For this application, the Model 700 is claiming substantial equivalency to the Chrono-log Corporation's Model 560 Aggregometer (K830749) with the Model 810 AGGRO/LINK (K851025) computer interface option currently in commercial distribution by Chrono-log Corp. The Model 700 has the ability to use the Chrono-log Disposable electrodes for which we demonstrate substantial equivalency to the Chrono-log Model 591A/592A (K032951) also currently in commercial distribution by Chrono-log Corporation.
The Model 700 Aggregometer uses many of the same parts as the Model 560 such as: Heater Blocks that hold the samples, LED and Photodiode circuit boards that measure changes in optical density for turbidometric aggregation, Impedance Electrodes used for impedance measurements in whole blood. Photomultiplier Tubes for measuring ATP release and stirring motors for sample stirring. The circuitry that connects to the measuring devices has been changed to more modern circuits. Provisions have been made so that the printed circuit boards for computer interface option can be placed inside the Aggregometer rather than be housed in a stand alone unit.
The chassis has also been redesigned and the front panel is improved with a Liquid Crystal Display (LCD) for displaying Temperature, Stirring Speed and Gain. The new front panel controls are tactile membrane switches. The chassis itself is shaped differently and has the ability for two units to interface together into a four channel configuration.
The output of the Model 700 series can be connected to either a strip chart recorder or to a Computer. Chrono-log provides software for the computer interface option as an accessory. The computer interface option is used to collect data and is not used for diagnosis or treatment and does not have any control over or input into the Model 700 Aggregometer.
2
11.4 Performance:
Comparison studies were run to compare the performance of the Model 700 to the Model 560 and the Model 591A for the disposable electrodes. Whole blood and Platelet Rich Plasma samples from normal, healthy, drug free subjects were tested with both instruments. The samples were tested using Chrono-log Collagen, ADP, Ristocetin, Epinephrine, Arachidonic Acid and Thrombin Reagents. The simultaneous measurement of ATP release was also measured using the luminescence technique. For ATP measurement CHRONO-LUME® was added to the sample.
The following concentrations of reagents were run: Collagen 2ug/mL and Spg/mL, ADP 5uM and 10uM, Arachidonic Acid 0.5 mM, Epinephrine SuM in PRP aggregation only, Ristocetin 1.0mg/mL for Whole Blood Aggregation and 1.25 mg/mL for PRP Aggregation and Thrombin for Luminescence measurement.
In Platelet Rich Plasma there were 149 comparison tests using optical aggregation with 167 Luminescence tests. In Whole Blood there were 267 comparison tests with Impedance Aggregation with 300 Luminescence tests. Although Aggregation and Luminescence are run simultaneously, there are always more Luminescence tests, because Aggregation is not measured with the thrombin reagent. At the recommended concentration, thrombin causes the platelets to clump in a single mass, which does not provide useful aggregation information. Thrombin at 1 unit concentration is used to measure the total amount of ATP in the platelets by Luminescence.
The Tables below show the correlation between the Model 700 and the Model 560
TABLE 9-1 Optical Aggregation in PRP
| No. of Samples | Pearson correlation coefficient | P-value |
|---|---|---|
| 149 | 0.8204 |