(29 days)
No
The device description and intended use clearly define it as an in-vitro diagnostic reagent (control material) for monitoring coagulation tests. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML. The performance studies focus on precision, which is typical for control materials, not algorithmic performance metrics.
No
The device is an in-vitro diagnostic reagent used to monitor the performance of coagulation testing, not to treat a disease or condition.
Yes
This device is described as an "in-vitro diagnostic reagent intended for clinical use as a control to monitor the performance of coagulation testing." This explicitly states its purpose within diagnostic procedures.
No
The device is described as lyophilized preparations of citrated plasma, which are physical substances, not software.
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 controls are "in-vitro diagnostic reagents intended for clinical use as a control to monitor the performance of coagulation testing". This directly aligns with the definition of an IVD, which are used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details the composition of the controls (lyophilized plasma) and how they are used in the context of coagulation testing (PT and APTT), which are common in-vitro diagnostic tests.
- Clinical Use: The intended user/care setting is "clinical use", further supporting its role in a diagnostic setting.
- Performance Studies: The inclusion of performance studies (precision studies) is typical for IVD devices to demonstrate their reliability and suitability for clinical use.
- Predicate Devices: The mention of predicate devices with K numbers indicates that this device is being compared to other legally marketed IVD devices.
- Reference Device: The reference device (MLA-900C Coagulometer) is a piece of equipment used for performing in-vitro diagnostic tests.
All of these factors strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Coagulation Control Levels 1, 2, and 3 are intended for clinical use as a control to monitor the performance of coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT). Level 1 yields result in the normal range. Level 2 vields results in the moderately abnormal range. Level 3 is intended to vield results in the extremely abnormal range.
Product codes (comma separated list FDA assigned to the subject device)
GGN
Device Description
The Coagulation Control Levels 1, 2 and 3 are lyophilized preparations of citrated plasma obtained from healthy donors, which are adjusted to yield prolonged PT and APTT values. Prior to lyophilization buffer and a stabilizer are added. The bulk plasma is tested using an FDA approved method for HBsAG, HIV antibodies and HCV antibodies and is certified for negativity for each batch.
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Within-run precision studies were performed and yielded substantially equivalent data as summarized in Tables 1 and 2 below.
Table 1: Within-run Precision Results using PT Reagents
Control Level: Level 1 (Normal), PT Vital Controls Average ± %CV, n = 20: 12.0 ± 1.1%, PT Reference Controls Average ± %CV, n = 20: 11.6 ± 0.7%
Control Level: Level 2 (Low abnormal), PT Vital Controls Average ± %CV, n = 20: 18.8 ± 1.4%, PT Reference Controls Average ± %CV, n = 20: 18.7 ± 1.2%
Control Level: Level 3 (High abnormal), PT Vital Controls Average ± %CV, n = 20: 32.6 ± 3.5%, PT Reference Controls Average ± %CV, n = 20: 32.6 ± 2.7%
Table 2: Within-run Precision Results using APTT Reagents
Control Level: Level 1 (Normal), APTT values of Vital Controls Average ± %CV, n = 20: 28.5 ± 2.3%, APTT values of Reference Controls Average ± %CV, n = 20: 24.9 ± 2.3%
Control Level: Level 2 (Low abnormal), APTT values of Vital Controls Average ± %CV, n = 20: 47.0 ± 1.7%, APTT values of Reference Controls Average ± %CV, n = 20: 54.8 ± 2.2%
Control Level: Level 3 (High abnormal), APTT values of Vital Controls Average ± %CV, n = 20: 61.2 ± 1.9%, APTT values of Reference Controls Average ± %CV, n = 20: 95.7 ± 2.3%
Between-run precision studies were performed and yielded substantially equivalent data as summarized in Tables 3 and 4.
Table 3: Day to Day Precision Results using PT Reagent
Day: Average (all days), PT values of Vital Controls Average ± %CV Level 1: 11.9, Level 2: 18.3, Level 3: 31.8
Day: %CV (between days), PT values of Vital Controls Average ± %CV Level 1: 1.5%, Level 2: 3.5%, Level 3: 4.5%
Day: Average (all days), PT values of Reference Controls Average ± %CV Normal: 11.5, Low Abnormal: 18.3, High Abnormal: 31.6
Day: %CV (between days), PT values of Reference Controls Average ± %CV Normal: 1.2%, Low Abnormal: 2.0%, High Abnormal: 3.3%
Table 4: Day to Day Precision Results using APTT Reagent
Day: Average (all days), APTT values of Vital Controls Average ± %CV Level 1: 28.5, Level 2: 46.7, Level 3: 61.8
Day: %CV (between days), APTT values of Vital Controls Average ± %CV Level 1: 1.8%, Level 2: 0.7%, Level 3: 3.9%
Day: Average (all days), APTT values of Reference Controls Average ± %CV Normal: 25.0, Low Abnormal: 54.5, High Abnormal: 94.1
Day: %CV (between days), APTT values of Reference Controls Average ± %CV Normal: 0.5%, Low Abnormal: 2.0%, High Abnormal: 2.7%
Vital Scientific concludes that the Coagulation Controls Levels 1,2, and 3 have a similar intended use, technological characteristics and performance data which support the statement that the Coagulation Controls Levels 1,2, and 3 are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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
§ 864.5425 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.
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Image /page/0/Picture/1 description: The image shows the logo for Vital Scientific. The logo consists of a stylized graphic to the left of the company name. The company name, "vital scientific", is written in a sans-serif font, with the word "vital" in a slightly larger font size than "scientific".
USA: One Gateway Center, Suite 415 New 1-617-527-9933. Ext. 22 Fax: 1-617-5
L: van Rensselaerweg 4. Spankeren 6 Fax:31-313-42780
510(k) Summary
Coaqulation Control Level 1, 2, 3
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510K number is: _ h022040
- Vital Scientific NV Applicant: One Gateway Center, Suite 415 Newton, MA 02158 Phone: 1-617-527-9933 x41 Fax: 1-617-527-8230
Israel M. Stein MD Contact:
Date: June 18, 2002
Device Name:
Coagulation Control Level 1, 2, 3 (Coaqulation Control Plasma). The Coagulation Control is also tradenamed the Vital Scientific Coagulation Control, and Quikcoag Coagulation Control. References in this document submission may use any of these names interchangeably.
Common Name:
Coagulation Control Plasma
Classification Name:
Coagulation Control Plasma has been classified as Class II device, 21 CFR 864.5425 (Product Code GGN). This device is intended for clinical use as a
1
control to monitor coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT).
Description of the Coagulation Control
The Coagulation Control Levels 1, 2 and 3 are lyophilized preparations of citrated plasma obtained from healthy donors, which are adjusted to yield prolonged PT and APTT values. Prior to lyophilization buffer and a stabilizer are added. The bulk plasma is tested using an FDA approved method for HBsAG, HIV antibodies and HCV antibodies and is certified for negativity for each batch.
Intended Use
The Coagulation Controls Levels 1, 2, and 3 are intended for clinical use as a control to monitor the performance of coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT). Level 1 yields result in the normal range. Level 2 vields results in the moderately abnormal range. Level 3 is intended to vield results in the extremely abnormal range.
Labeling:
This device is labeled in accordance with 21 CFR 801.
Substantial Equivalence:
The Coagulation Control Level 1 was compared to Precision Biologic Pooled Normal Plasma (K952662). The Coagulation Control 2 was compared with the Assess Low Abnormal Control from Instrumentation laboratory (K931117). The Coagulation Control 3 was compared with the Assess High Abnormal Control from Instrumentation Laboratory (K931118) on the MLA-900C Coagulometer (K884863).
Within-run precision studies were performed and yielded substantially equivalent data as summarized in Tables 1 and 2 below.
| Control Level | PT Vital Controls
Average ± %CV, n = 20 | PT Reference Controls
Average ± %CV, n = 20 |
|-------------------------|--------------------------------------------|------------------------------------------------|
| Level 1 (Normal) | 12.0 ± 1.1% | 11.6 ± 0.7% |
| Level 2 (Low abnormal) | 18.8 ± 1.4% | 18.7 ± 1.2% |
| Level 3 (High abnormal) | 32.6 ± 3.5% | 32.6 ± 2.7% |
Table 1: Within-run Precision Results using PT Reagents
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Page 3
Table 2: Within-run Precision Results using APTT Reagents
| Control Level | APTT values of Vital Controls
Average ± %CV, n = 20 | APTT values of Reference Controls
Average ± %CV, n = 20 |
|-------------------------|--------------------------------------------------------|------------------------------------------------------------|
| Level 1 (Normal) | 28.5 ± 2.3% | 24.9 ± 2.3% |
| Level 2 (Low abnormal) | 47.0 ± 1.7% | 54.8 ± 2.2% |
| Level 3 (High abnormal) | 61.2 ± 1.9% | 95.7 ± 2.3% |
Between-run precision studies were performed and yielded substantially equivalent data as summarized in Tables 3 and 4.
Table 3: Day to Day Precision Results using PT Reagent
| Day | PT values of Vital Controls
Average ± %CV | | | PT values of Reference Controls
Average ± %CV | | |
|--------------------------|----------------------------------------------|---------|---------|--------------------------------------------------|--------------|------------------|
| | Level 1 | Level 2 | Level 3 | Normal | Low Abnormal | High
Abnormal |
| Average
(all days) | 11.9 | 18.3 | 31.8 | 11.5 | 18.3 | 31.6 |
| %CV
(between
days) | 1.5% | 3.5% | 4.5% | 1.2% | 2.0% | 3.3% |
Table 4: Day to Day Precision Results using APTT Reagent
| Day | APTT values of Vital Controls
Average ± %CV | | | APTT values of Reference Controls
Average ± %CV | | |
|--------------------------|------------------------------------------------|---------|---------|----------------------------------------------------|--------------|------------------|
| | Level 1 | Level 2 | Level 3 | Normal | Low Abnormal | High
Abnormal |
| Average
(all days) | 28.5 | 46.7 | 61.8 | 25.0 | 54.5 | 94.1 |
| %CV
(between
days) | 1.8% | 0.7% | 3.9% | 0.5% | 2.0% | 2.7% |
Vital Scientific concludes that the Coagulation Controls Levels 1,2, and 3 have a similar intended use, technological characteristics and performance data which
3
support the statement that the Coagulation Controls Levels 1,2, and 3 are substantially equivalent to the predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
JUL 2 3 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Israel M. Stein, MD Managing Director US Branch OfficeVital Scientific One Gateway Center Suite 415
K022046 Re:
Newton, MA 02158
Trade/Device Name: Coagulation Control Levels 1, 2, and 3 Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN Dated: June 21, 2002 Received: June 24, 2002
Dear Dr. Stein:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsmamain.html".
Sincerely yours.
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K O2 30 40 40 ______________________________________________________________________________________________________________________________________
Device Name: Coagulation Control Levels 1, 2, and 3
Indications For Use:
(Per 21-CFR-801.109)
The Coagulation Controls Levels 1, 2, and 3 are in-vitro diagnostic reagents intended for clinical use as a control to monitor the performance of coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT). Level 1 yields result in the normal range. Level 2 yields results in the moderately abnormal range. Level 3 is intended to yield results in the extremely abnormal range.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign (Off) 02204 Division of Clinical Laboratory Devices 510(k) Number -Prescription Use Over-The-Counter Use
OR
(Optional Format 1-2-96)