(134 days)
No
The device description and performance studies focus on the physical and chemical properties of the control solutions and their stability, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is described as controls for a quality control system, intended to assure the accuracy of test results, not to treat or diagnose a disease.
No
This device is described as a "control" used for quality control of the TAS Analyzer and HMT cards, ensuring they are "functioning properly and thereby help assure the accuracy of the HMT test results." It does not directly diagnose a patient's condition.
No
The device description clearly details physical components (vials, ampule, plastic sleeve, diluent, dropper top, filter tip) and a physical process (crushing the ampule, mixing, dispensing drops) for the controls. This is a physical reagent/control, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are used "to provide a method for quality control of the system" (TAS Analyzer and HMT cards) and "to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of the HMT test results." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. In this case, the controls are used to ensure the accuracy of a test that provides information about a patient's coagulation status.
- Device Description: The controls are made with human plasma, which is a specimen derived from the human body.
- Function: The controls are used in vitro (outside the body) with the TAS Analyzer and HMT cards to assess the performance of the test system.
While the controls themselves don't directly diagnose a patient, they are essential components of an IVD system (the TAS Analyzer and HMT cards) and are used in vitro to ensure the reliability of the results obtained from patient samples. The FDA's classification of these controls as substantially equivalent to other controls used in coagulation assays further supports their classification as IVDs.
N/A
Intended Use / Indications for Use
The new TAS HMT controls are intended to be used with the TAS Analyzer and HMT cards, previously cleared to market by the FDA, to provide a method for quality control of the system. The controls produce clotting times which must be within accepted, standard ranges, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of the HMT test results. The controls are substantially equivalent in intended use to other controls used in coagulation assays.
Product codes
Not Found
Device Description
The controls for TAS HMT cards consists of two separate vials. One was designed to mimic a sample from a normal individual, and the second to mimic a sample from a patient on a high dose of heparin. These controls are made with human plasma screened for antibodies to and antigens of human immunodeficiency and hepatitis viruses. To make the controls as easy to use as possible for point-of-care testing, we chose the patented packaging system of EDItek, This consists of a closed, crushable qlass ampule containing Ivophilized plasma which is inside a plastic sleeve. The sleeve contains water for diluent and has a capped dropper top with a filter tip. The entire assembly is shrink wrapped with a label and plastic seal. To use, the ampule is crushed inside the plastic sleeve, which allows the diluent to mix with the lyophilized plasma. The mixture is reconstituted by shaking or vortexing the capped vial. The plastic seal and cap are removed, two drops of plasma are discarded into a waste container, and a drcp of the plasma suspension is added to a TAS HMT test card in an analyzer. The rest of the test procedure and the manner of signal production is identical to that for a patient sample.
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)
Nonclinical Performance Data:
HMT controls are stable for at least 15 weeks of storage at room temperature. indicating a probable refrigerator stability of at least one year. Controls produced acceptable results for about 30 minutes after reconstitution, but we recommend that they be run as soon as possible after reconstitution, preferably within five minutes.
Within day, day to day, operator, lot to lot, vial to vial, drop to drop variation studies all produced mean ranges of 133 - 153 and 235 - 260 for the normal and heparin controls, respectively, with CV ranging from 5 to 9%.
Freezing or warming of the intact vials to incubator temperatures for short periods of time has little, if any, effect on the performance of these controls - there was no significant difference in mean or CV for any of the samples tested compared to vials stored in the refrigerator. Temperature of the vials or sample temperature has little, if any effect on the HMT cards results produced with these controls. The angle at which drops from the control vials are dispensed has no significant effect on the mean clotting times or the CV of the results.
Clinical Performance Data:
Studies were performed at two clinical study sites and at CDI to establish the performance of the TAS HMT controls in the field. At each of the clinical study sites, the TAS HMT normal and heparin controls were tested in duplicate each day for 20 days with the TAS Analyzer and HMT test cards to determine variation.
Site A: Normal Mean 135, Normal CV 9.8; Heparin Mean 245, Heparin CV 4.2
Site B: Normal Mean 133, Normal CV 8.3; Heparin Mean 245, Heparin CV 3.2
CDI: Normal Mean 150, Normal CV 7.9; Heparin Mean 259, Heparin CV 6.4
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
Image /page/0/Picture/0 description: The image shows the logo for Cardiovascular Diagnostics Inc. The logo features the letters 'CD' in a stylized font, with a triangle shape behind them. The text 'CARDIOVASCULAR DIAGNOSTICS INC.' is written above the symbol in a smaller font.
MAY 3 0 1996
510(k) Summary
- Cynthia Pritchard, Ph.D. Submitted by: Director of Test Development
- Cardiovascular Diagnostic, Inc. Address: 5301 Departure Drive Raleigh, NC 27604
- Phone: 1-919-954-9871, ext. 248
- Fax:
1-919-954-9932
- Cynthia Pritchard, Ph.D. Contact: Director of Test Development
Date of Summary: January 10, 1995
1
HMT Controls VI. Summary of Safety and Effectiveness Information
Trade name: Thrombolytic Assessment System Heparin Management Test Controls (TAS HMT controls)
Common Name: in vitro coaqulation controls
Classification Name: systems for in vitro coagulation studies, automated or semiautomated instruments and associated reagents and controls used to perform a series of coagulation studies and coagulation factor assays (Class II. 21 C.F.R. 864.5425)
Predicate Device: In clinical comparison studies the TAS HMT controls provided results that compared well with legally marketed controls, the ACT-trol controls for the Activated Clotting Time Test (Analytical Control Systems, ACS) when used to test the operation of the instrument and test cards. The TAS HMT controls are substantially equivalent to the ACS controls. These latter controls are used in conjunction with disposable tubes for the Hemochron or Hemotec devices, which are used to determine a patient's response to high doses of heparin, which also is the intended use of the TAS Analyzer and HMT cards (see K943283).
Description of the Device: The controls for TAS HMT cards consists of two separate vials. One was designed to mimic a sample from a normal individual, and the second to mimic a sample from a patient on a high dose of heparin. These controls are made with human plasma screened for antibodies to and antigens of human immunodeficiency and hepatitis viruses. To make the controls as easy to use as possible for point-of-care testing, we chose the patented packaging system of EDItek, This consists of a closed, crushable qlass ampule containing Ivophilized plasma which is inside a plastic sleeve. The sleeve contains water for diluent and has a capped dropper top with a filter tip. The entire assembly is shrink wrapped with a label and plastic seal. To use, the ampule is crushed inside the plastic sleeve, which allows the diluent to mix with the lyophilized plasma. The mixture is reconstituted by shaking or vortexing the capped vial. The plastic seal and cap are removed, two drops of plasma are discarded into a waste container, and a drcp of the plasma suspension is added to a TAS HMT test card in an analyzer. The rest of the test procedure and the manner of signal production is identical to that for a patient sample.
Intended Use: The new TAS HMT controls are intended to be used with the TAS Analyzer and HMT cards, previously cleared to market by the FDA, to provide a method for quality control of the system. The controls produce clotting times which must be within accepted, standard ranges, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of the HMT test results. The controls are substantially equivalent in intended use to other controls used in coagulation assays.
2
Summary of Safety and Effectiveness Information
HMT Controls
| Characteristic | HMT Controls | ACT Controls |
|---|---|---|
| Intended use | assure performance of system | |
| by functional testing | same | |
| For use with | HMT cards that measure | |
| response to heparin | tests that measure | |
| response to heparin | ||
| Format | glass ampule in plastic sleeve | capped glass bottle |
| Reagent | lyophilized plasma | same |
| Diluent | water | same |
| Source | human | same or animal |
| Reaction | formation of a fibrin clot | same |
| Results | clotting time | same |
| Interpretation of results | system OK if clotting times | |
| are within set limits | same |
Comparison of the TAS HMT Controls to the Marketed Controls:
There were no significant differences in the performance of the HMT controls and the controls from other manufacturers used as predicate device. The normal controls produce a clotting time like that of a normal individual (but have different times for different reagent/instrument combinations). As other control manufacturers, we chose to make an abnormal control that responded as a patient would that is near the midrange in heparin response. The method of packaging TAS controls is different, to make them more "user-friendly" for point-of-care testing. With this system, an operator does not have to search for a pipetting device and reagent-grade water for reconstitution, and does not have to wait 30 minutes for the reagent to reconstitute.
Nonclinical Performance Data:
HMT controls are stable for at least 15 weeks of storage at room temperature. indicating a probable refrigerator stability of at least one year. Controls produced acceptable results for about 30 minutes after reconstitution, but we recommend that they be run as soon as possible after reconstitution, preferably within five minutes.
3
Summary of Safety and Effectiveness Information
HMT Controls
Within day, day to day, operator, lot to lot, vial to vial, drop to drop variation studies all produced mean ranges of 133 - 153 and 235 - 260 for the normal and heparin controls, respectively, with CV ranging from 5 to 9%.
Freezing or warming of the intact vials to incubator temperatures for short periods of time has little, if any, effect on the performance of these controls - there was no significant difference in mean or CV for any of the samples tested compared to vials stored in the refrigerator. Temperature of the vials or sample temperature has little, if any effect on the HMT cards results produced with these controls. The angle at which drops from the control vials are dispensed has no significant effect on the mean clotting times or the CV of the results.
Clinical Performance Data:
Studies were performed at two clinical study sites and at CDI to establish the performance of the TAS HMT controls in the field. At each of the clinical study sites, the TAS HMT normal and heparin controls were tested in duplicate each day for 20 days with the TAS Analyzer and HMT test cards to determine variation.
| Normal | Heparin | |||
|---|---|---|---|---|
| Mean | CV | Mean | CV | |
| Site A | 135 | 9.8 | 245 | 4.2 |
| Site B | 133 | 8.3 | 245 | 3.2 |
| CDI | 150 | 7.9 | 259 | 6.4 |
Conclusions: TAS HMT controls are substantially equivalent to the predicate device because they have the same intended use and the similar technological characteristics. This application includes sufficient information to demonstrate that the TAS HMT controls, to be used with the TAS Analyzer (K933092) and TAS HMT cards (K943283), are safe and effective as a legally marketed device, and that they do not raise different questions of safety and efficacy.