(134 days)
No
The summary describes a reagent for a standard laboratory test and does not mention any AI or ML components.
No
This device is an in-vitro diagnostic reagent used for Activated Partial Thromboplastin Time (APTT) testing to detect coagulation abnormalities. It is used for diagnostic purposes, not for treating any condition.
Yes
The document explicitly states "The Vital Scientific APTT is an in-vitro diagnostic reagent".
No
The device description clearly states it is an "in-vitro diagnostic reagent" and describes its use in a manual method for APTT testing, involving the addition of a suspension of rabbit brain cephalin. This indicates a physical reagent, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first section explicitly states "The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing..." This directly identifies it as an in-vitro diagnostic reagent.
- Device Description: The description details how the reagent is used to determine APTT and coagulation factor assays, which are tests performed on biological samples (blood) outside of the body.
- Intended User/Care Setting: It specifies use in a "clinical laboratory," which is a typical setting for IVD testing.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device, which is a medical device used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions.
N/A
Intended Use / Indications for Use
The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.
Product codes
GFO
Device Description
The APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic homeostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit brain cephalin with a surface activator.
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
manual method in a clinical laboratory
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
Correlation studies were performed. One study used 107 patient plasmas (30 normal, 77 undergoing heparin therapy) and was performed on the MLA 900C coagulometer. The correlation coefficient was 0.938. Another correlation study used 107 patient plasmas (30 normal, 77 undergoing heparin therapy) and was performed on an ACL-100 coagulometer. The correlation coefficient was 0.930. Day to Day and Within-run Precision studies were performed. All within-run %CV values were less than 5 %. All day to day %CV values were less than 5%.
Key Metrics
Correlation coefficient for MLA 900C coagulometer study: 0.938; slope: 0.727; intercept: 6.96.
Correlation coefficient for ACL-100 coagulometer study: 0.930; slope: 0.952; intercept: 3.76.
Within-run Precision: All %CV values less than 5%.
Day to Day Precision: All %CV values less than 5%.
Predicate Device(s)
Reference Device(s)
MLA 900C coagulometer (K884863), ACL-100 coagulometer (K881367)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).
0
NOV 1 2002
vital scientific
USA: One Gateway Center, Suite 415 Newton, MA 02158
1-617-527-9933, Ext. 22 Fax: 1-617-527-8230
NL: van Rensselaerweg 4, Spankeren 6956AV, NL
-31-313-43500 Fax:31-313-427807
510(k) Summary
Vital Scientific APTT
The assigned 510K number is: K022021
Applicant: Vital Scientific NV One Gateway Center, Suite 415 Newton, MA 02158 Phone: 1-617-527-9933 x41 Fax: 1-617-527-8230
Contact: Israel M. Stein MD
October 30, 2002 Date:
Device Name:
Vital Scientific APTT (In-vitro diagnostic reagent). The Vital Scientific APTT is also tradenamed the QuikCoag APTT, and APTT. References in this document submission may use these names interchangeably.
Common Name:
Activated Partial Thromboplastin Time (APTT)
Classification Name:
Activated Partial Thromboplastin - has been classified as Class II device, as per 21 CFR 864.7925 (Product Code GFO). This device is intended for clinical use in conjunction with an analyzer to measure clot formation.
Description of the APTT
The APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a
1
● Page 2
modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic homeostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit brain cephalin with a surface activator.
Intended Use
The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.
Labeling:
This device is labeled in accordance with 21 CFR 801.
Substantial Equivalence:
The safety and effectiveness of APTT has been demonstrated by showing its substantial equivalence to APTT-LS manufactured by Fisher Diagnostics (formerly Pacific Hemostasis) K891337.
A correlation study was performed using a total of 107 patient plasmas; 30 from patients with normal APTT values and 77 with patients undergoing heparin therapy. The assays were performed on the MLA 900C coagulometer (K884863). The correlation coefficient for all plasmas was 0.938 and the slope is 0.727 and the intercept is 6.96, indicating acceptable correlation between the two reagents. The results are plotted on the following graph.
Image /page/1/Figure/10 description: This image is a scatter plot titled "APTT reagent Correlation on MLA Electra 800C". The x-axis is labeled "Vital APTT clotting time (sec.)" and ranges from 20.0 to 80.0. The y-axis is labeled "Reference APTT-LS clotting time (sec.)" and ranges from 20.0 to 90.0. The data points show a positive correlation between the two APTT clotting times, and a trend line is drawn through the data.
A correlation study of these reagents was also performed on an ACL-100 coagulometer (K881367) in the clinical laboratory of a community hospital using
2
October 30, 2002
· Page 3
a total of 107 patient plasmas; 30 from patients with normal APTT values and 77 with patients undergoing heparin therapy. The correlation coefficient for all plasmas was 0.930, the slope was 0.952 and the intercept was 3.76, indicating acceptable correlation between the two reagents. The results are plotted on the following graph.
Image /page/2/Figure/3 description: The figure is a scatter plot titled "APTT Correlation on ACL 100". The x-axis is labeled "BioMadica APTT" and ranges from 20 to 140. The y-axis is labeled "Pacific Hemostasis APTT-LS" and ranges from 20 to 120. There is a positive correlation between the two variables.
Day to Day and Within-run Precision studies were performed. All within-run %CV values were less than 5 %. The day to day precision is the %CV of the average APTT value obtained over five days. All day to day %CV values were less than 5%. The day to day and within run precision of Vital APTT and the predicate device APTT reagent were equivalent. The results for the within-run precision are shown in Table 1 and for the day to day precision is shown in Table 2 below:
| Controls | Vital APTT | Reference APTT-LS | ||
|---|---|---|---|---|
| Average (n=16) | % CV | Average (n=16) | %CV | |
| Normal | 24.2 | 1.1 % | 25.0 | 2.3 % |
| Low Abnormal | 43.3 | 4.3 % | 55.0 | 2.3 % |
| High Abnormal | 73.8 | 4.3 % | 94.7 | 2.4 % |
| Average Precision | 3.2 % | 2.3 % |
Table 1 Within-run Precision
3
| Vital APTT | Reference APTT-LS | |||
|---|---|---|---|---|
| Average | %CV | Average | %CV | |
| Normal Control | ||||
| Average (n=5) | 24.2 | 1.4 % | 25.0 | 2.4 % |
| Day to Day % CV | 3.6 % | 0.2 % | ||
| Low Abnormal | ||||
| Average (n=5) | 41.9 | 2.7 % | 54.4 | 2.1 % |
| Day to Day % CV | 2.5 % | 1.9 % | ||
| High Abnormal | ||||
| Average (n=5) | 70.2 | 3.3 % | 93.8 | 1.9 % |
| Day to Day % CV | 4.0 % | 2.6 % |
Table 2: Day to Day Precision
Vital Scientific concludes that the APTT has a similar intended use, a similar technological principle, and clinically acceptable performance comparable to similar devices currently in commercial distribution and is substantially equivalent to the predicate device.
:
:
・
.
・
:
.
,
,
:
:
4-4
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird 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 bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Israel M. Stein, M.D. Managing Director Vital Scientific NV One Gateway Center, Suite 415 Newton, MA 02158
Re: K022021
Trade/Device Name: Vital Scientific APTT Regulation Number: 21 CFR 864.7925 Regulation Name: Partial Thromboplastin Time Tests Regulatory Class: Class II Product Code: GFO Dated: September 30, 2002 Received: October 3, 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
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/cdrlvdsma/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
6
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K022021
Device Name: Vital Scientific APTT
Indications For Use:
The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Qffice of Device Evaluation (ODE)
Thushine Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K02262
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)