(122 days)
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No
The device is a blood collection tube and the description focuses on its physical components and function in collecting and processing blood samples for laboratory assays. There is no mention of any computational or analytical capabilities that would involve AI/ML.
No.
The device is used for collecting, transporting, separating, and processing blood for clinical laboratory assays, not for treating a disease or condition.
No
The device is a blood collection tube used for collecting, transporting, separating, and processing blood specimens for clinical laboratory assays. It does not perform diagnostic functions itself, but rather prepares samples for diagnostic tests.
No
The device is a physical blood collection tube with a clot activator and barrier gel, not a software program.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the collected specimens are used for "clinical laboratory assays involving the use of patient serum." This directly aligns with the definition of an IVD, which are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a device designed for "collecting, transporting, separating, and processing blood," which are all steps involved in preparing a specimen for in vitro diagnostic testing.
- Performance Studies: The performance studies compare the device to a predicate device (BD Vacutainer ™ Plus SST ™ Tube) for use in "chemistry assays." Chemistry assays are a common type of in vitro diagnostic test.
- Predicate Device: The predicate device listed (BD Vacutainer ™ Plus SST ™ Tube) is also a blood collection tube used for diagnostic testing, further supporting the classification of this device as an IVD.
- Intended User/Care Setting: The intended user is a "clinical laboratory," which is the typical setting where in vitro diagnostic testing is performed.
While the document doesn't explicitly state "In Vitro Diagnostic Device," the intended use, device description, and context of its use in clinical laboratory assays for patient serum strongly indicate that it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
Teco Blood Specimen Collection Devices: Vacu lab Plain Tube and Vacu Lab Gel & Clot Activator Tube provide a means for collection, processing and transportation of blood in a closed system. Blood collected in these tubes is primarily used for clinical laboratory chemistry assays, but may be used for other assays requiring serum specimens as determined by the laboratory.
- The Vacu Lab Plain Tube is a sterile, plastic, evacuated blood collection tube with a silica clot activator that provides a means of collecting, transporting, separating, and processing blood in a closed tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
- The Vacu Lab Gel & Clot Activator Tube is a sterile, plastic, evacuated blood collection tube with a silica clot activator and a barrier gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
The Teco Blood Collection Devices include: Vacu Lab Plain Tube; Vacu Lab Gel & Clot Activator Tube;
- The Vacu Lab Plain Tube is sterile, plastic, evacuated blood collection tube. The tube consists of (1) a closure assembly, (2) a silica clot activator, and (3) a silicone surfactant coated plastic tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
- The Vacu Lab Gel & Clot Activator Tube is sterile, plastic, evacuated blood collection tube. The tube consists of (1) a closure assembly, (2) a silica clot activator, (3) a Barrier Gel and (4) a silicone surfactant coated plastic tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
Mentions image processing
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Mentions AI, DNN, or ML
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison of Vacu Lab Plain Tube; Vacu Lab Gel & Clot Activator Tube to BD Vacutainer ™ Plus SST ™ Tube following the guidelines of NCCLS Guideline EP9-A2 was conducted.
Clinical evaluations were performed to determine the safety and efficiency of Teco Blood Specimen Collection Devices: Vacu lab Plain Tube and Vacu Lab Gel & Clot Activator Tube. The devices were compared to the predicate devices BD Vacutainer ™ Plus SST ™ Tube. The results of the clinical evaluation demonstrated that the Teco Blood Specimen Collection Devices: Vacu lab Plain Tube and Vacu Lab Clot Activator Tube provide clinically equivalent chemistry analyte results when compared to the BD Vacruainer TM Plus SST TM Tube.
Four studies were conducted to evaluate the use of Teco Blood Specimen Collection Devices: Vacu lab Plain Tube and Vacu Lab Gel & Clot Activator Tube in chemistry assays.
Study I: Evaluated the use of the Vacu Lab Plain Tube. The objective was to demonstrate substantial equivalence to the Becton Dickinson (BD) Vacutainer TM Plus SSS ™ Tube (K023075) when samples from these tubes are used in chemistry assays including total protein, Albumin, Total Bilirubin, Direct Bilirubin, AST, ALT, ALP, r-GT, Cholesterol. A total of 66 paired samples were collected from outpatients and tested on Hitachi 717. The Vacu Lab Plain Tube demonstrated equivalent results to the predicate device.
Study II: Continuous evaluation of the Vacu Lab Plain Tube. Randomly collected 25 outpatient blood samples. Drew the same amount of blood from each patient into the Vacu Lab Plain Tube and BD Vacutainer TM Plus SST ™ Tube and centrifuged for 10 minutes. Tested the supernatant. Assays performed on Beckman CX7, Hitachi 912 and Elisa Reader TC98 included potassium, glucose, creatinine, calcium, chloride, creatinine kinase (CK), human chorionic gonadotropin (HCG), magnesium, phosphorous, triglyceride, uric acid, blood urea nitrogen (BUN), sodium, CK-MB, thyroid stimulating hormone (TSH), Free T4, ferritin, prolactin, total protein, albumin, total bilirubin, direct bilirubin, AST, ALT, ALP, r-GT and Cholesterol. Tests conducted within 8 hours after collecting samples. The Vacu Lab Plain Tube demonstrated equivalent results to the predicate device.
Study III: Evaluated the use of Vacu Lab Gel & Clot Activator Tube. The objective was to demonstrate substantial equivalence to the Becton Dickinson (BD) Vacutainer ™ Plus SST TM Tube (K023075) when samples from these tubes are used in chemistry assays including total protein, Albumin, Total Bilirubin, Direct Bilirubin, AST, ALT, ALP, r-GT, Cholesterol. A total of 70 paired samples were collected from outpatients and tested on Hitachi 717. The Vacu Lab Gel & Clot Activator Tube demonstrated equivalent results to the predicate device.
Study IV: Continuous evaluation of Vacu Lab Gel & Clot Activator Tube. Randomly collected 25 outpatient blood samples. Drew the same amount of blood from each patient into Vacu Lab Gel & Clot Activator Tube and BD Vacutainer TM Plus SST TM Tube and Centrifuged for 10 minutes. Tested the supernatant. Assays performed on Beckman CX7, Hitachi 912 and Elisa Reader TC98 included potassium, glucose, creatinine, calcium, chloride, creatinine kinase (CK), human chorionic gonadotropin (HCG), magnesium, phosphorous, triglyceride, uric acid, blood urea nitrogen (BUN), sodium, CK-MB, thyroid stimulating hormone (TSH), Free T4, ferritin, prolactin, albumin, total bilirubin, direct bilirubin, AST, ALT, ALP, r-GT and Cholesterol. Tests conducted within 8 hours after collecting samples. The Vacu Lab Gel & Clot Activator Tube demonstrated equivalent results to the predicate device.
All comparison studies yield correlation coefficient ≥ 0.95. An acceptable correlation coefficient for all comparison studies is ≥ 0.95.
Stability Studies of Specimens: Studies were conducted to compare fresh specimens (8 hours after collecting samples) and 72 hours stored at 2-8 ℃. All results showed no significant different from fresh specimens and 72 hours stored at 2-8 ℃. All comparison studies yield correlation coefficient > 0.95. An acceptable correlation coefficient for all comparison studies is ≥ 0.95.
Shelf- life Studies: Based on accelerated aging theory, Q10 method. Tubes were put in a 60 centigrade oven for 50 days to achieve equivalency to at least 24 months of real-life aging of Vacu Lab Plain Tube and Vacu Lab Gel & Clot Activator Tube at 4-30 centigrade. The calculation for real time shelf life was 50 x 2^((60-20)/10) = 50 x 2^4 = 800 days. Claimed shelf life is 2 years. After 50 days in the oven, 25 outpatient blood specimens were collected. Blood was drawn into Vacu Lab Plain Tubes, Vacu Lab Gel & Clot Activator Tubes, and BD Vacutainer TM Plus SST TM Tubes for comparison studies. All tests were undertaken on Hitachi 912 and Elisa Reader TC 98. The results of comparison studies did not show any significant difference from the results of BD Vacutainer TM Plus SST TM Tubes. All comparison studies yield correlation coefficient ≥ 0.95. An acceptable correlation coefficient for all comparison studies is ≥ 0.95.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient ≥ 0.95
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.
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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
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
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TECO DIAGNOSTICS
Image /page/0/Picture/3 description: The image shows a black hexagon with the letters "TC" in white inside. The letters are in a simple, sans-serif font. The hexagon is solid black, providing a strong contrast to the white letters. The overall design is simple and modern.
1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Email:tecodiag@tecodiag.com
510 K Summary Teco Vacu Lab. Plain Tube & Vacu Lab Gel & Clot Activator Tube
Device Name
The device trade names and common/classifications name are:
| Device Trade Name | Common/Classification Name |
|---|---|
| Teco Blood Specimen Collection Devices: | |
| Vacu lab Plain Tube | |
| Vacu Lab Gel & Clot Activator Tube | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Address and Registration
The address and registration number of the manufacturer site for Teco Blood Specimen Collection Devices.
TECO Diagnostics 1268 N. Lakeview Ave. Anaheim, CA 92807, U.S.A. FDA Registration # 1832216
Contact Person: Jian Vaeches Prepared Date: 03/12/2006
Device Class
Teco Blood Specimen Collection Devices have been classified as Class II with Product Code JKA"in vitro" diagnostics devices having the classification number: 21 CFR. 862.1675. This is the description available from the classification names listed in the " CDRH Home Page- Listing Database."
Labeling and Intended Use
Draft labels and Instructions for use can be found in appendix A.
Intended Use
Teco Blood Specimen Collection Devices: Vacu lab Plain Tube and Vacu Lab Gel & Clot Activator Tube provide a means for collection, processing and transportation of blood in a closed system. Blood collected in these
1
tubes is primarily used for clinical laboratory chemistry assays, but may be used for other assays requiring serum specimens as determined by the laboratory.
Device Description
The Teco Blood Collection Devices include: Vacu Lab Plain Tube; Vacu Lab Gel & Clot Activator Tube;
-
- The Vacu Lab Plain Tube is sterile, plastic, evacuated blood collection tube. The tube consists of (1) a closure assembly, (2) a silica clot activator, and (3) a silicone surfactant coated plastic tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
-
- The Vacu Lab Gel & Clot Activator Tube is sterile, plastic, evacuated blood collection tube. The tube consists of (1) a closure assembly, (2) a silica clot activator, (3) a Barrier Gel and (4) a silicone surfactant coated plastic tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
Method Comparison of Vacu Lab Plain Tube; Vacu Lab Gel & Clot Activator Tube to BD Vacutainer ™ Plus SST ™ Tube following the guidelines of NCCLS Guideline EP9-A2 was conducted.
Substantial Equivalence
Base on a comparison of the device features, materials and intended use, the Teco Blood Specimen Collection Device: Vacu lab Plain Tube and Vacu Lab Gel & Clot Activator Tube is substantially equivalent to the predicate devices.
The predicate device is BD Vacutainer TM Plus SST TM Tube The 510 (K) approval letter is provided in Appendix I. 510(K) #: K023075 Approval Date: 11-25-2002
Synopsis of Test Methods and Results
Comparison Studies:
Clinical evaluations were performed to determine the safety and efficiency of Teco Blood Specimen Collection Devices: Vacu lab Plain Tube and Vacu Lab Gel & Clot Activator Tube. The devices were compared to the predicate devices BD Vacutainer ™ Plus SST ™ Tube. The results of the clinical evaluation demonstrated that the Teco Blood Specimen Collection Devices: Vacu lab Plain Tube and Vacu Lab Clot Activator Tube provide clinically equivalent chemistry analyte results when compared to the BD Vacruainer TM Plus SST TM Tube.
Four studies were conducted to evaluate the use of Teco Blood Specimen Collection Devices: Vacu lab Plain Tube and Vacu Lab Gel & Clot Activator Tube in chemistry assays.
Study I was conducted to evaluate the use of the Vacu Lab Plain Tube. The objective of the studies was to demonstrate substantial equivalence to the Becton Dickinson (BD) Vacutainer TM Plus SSS ™ Tube (K023075) when samples from these tubes are used in chemistry assays included total protein, Albumin, Total Bilirubin, Direct Bilirubin, AST, ALT, ALP, r-GT, Cholesterol. A total 66 paired samples were collected from outpatients and samples were tested on Hitachi 717. The Vacu Lab Plain Tube demons "rated equivalent results to the predicate device.
Study II was continuous conducted to evaluate the use of the Vacu Lab Plain Tube. Randomly collect outpatient blood samples 25. Draw the same amount blood from each patient into the Vacu Lab Plain Tube and BD Vacutainer TM Plus SST ™ Tube and Centrifye 10 minutes. Test the supermatant. Assays performed on Beckman CX7, Hitachi 912 and Elisa Reader TC98 included potassium, glucose, creatinine, calcium, chloride, creatinine kinase (CK), human chorionic gonadotropin (HCG), magnesium, phosphorous, triglyceride, uric acid, blood urea nitrogen (BUN), sodium, CK-MB, thyroid stimulating homone (TSS), Free T4, ferritin, prolactin, total protein, albumin, total bilirubin, direct bilirubin, AST, ALT, J.J. J.-GT
2
and Cholesterol. Test conducted within 8 hours after collecting samples. The Vacu Lab Plain Tube demonstrated equivalent results to the predicate device.
Study III was conducted to evaluate the use of Vacu Lab Gel & Clot Activator Tube. The objective of the studies was to demonstrate substantial equivalence to the Becton Dickinson (BD) Vacutainer ™ Plus SST TM Tube (K023075) when samples from these tubes are used in chemistry assays included total protein, Albumin, Total Bilirubin, Direct Bilirubin, AST, ALT, ALP, r-GT, Cholesterol. A total 70 paired samples were collected from outpatients and samples were tested on Hitachi 717. The Vacu Lab Gel & Clot Activator Tube demonstrated equivalent results to the predicate device.
Study IV was continuous to evaluate the use of Vacu Lab Gel & Clot Activator Tube. Randomly collect outpatient blood samples 25. Draw the same amount blood from each patient into Vacu Lab Gel & Clot Activator Tube and BD Vacutainer "" Plus SST TM Tube and Centrifuge 10 minutes. Test the supernatiant. Assays performed on Beckman CX7, Hitachi 912 and Elisa Reader TC98 included potassium, glucose, creatinine, calcium, chloride, creatinine kinase (CK), human chorionic gonadotropin (HCG), magnesium, phosphorous, triglyceride, uric acid, blood urea nitrogen (BUN), sodium, CK-MB, thyroid stimulating hormone (TSH), Free T4, ferritin, prolactin, albumin, total bilirubin, direct bilirubin, AST, ALT, ALP,r-GT and Cholesterol. Test conducted within 8 hours after collecting samples. The Vacu Lab Gel & Clot Activator Tube demonstrated equivalent results to the predicate device.
All comparison studies yield correlation coefficient ≥ 0.95. An acceptable correlation coefficient for all comparison studies is ≥ 0.95
Stability Studies of Specimens
Studies were conducted to compare fresh specimens (8 hours after collecting samples) and 72 hours stored at 2-8 ℃. All results showed no significant different from fresh specimens and 72 hours stored at 2-8 ℃.
All comparison studies yield correlation coefficient > 0.95. An acceptable correlation coefficient for all comparison studies is ≥ 0.95
Shelf- life Studies
The shelf studies are based on accelerated aging theory, Q 10 method. Put tubes in 60 centigrade oven for 50 days, to achieve equivalency at least 24 months of real life aging of Vacu Lab Plain Tube and Vacu Lab Gel & Clot Activator Tube at 4-30 centigrade. The calculation as below:
The real time shelf life = Oven aging times (days) X Q (0) (0)en aging temperature-storage temperature) 10-50 x 2 (60-20) 10 =50 x 2 4 =800 days. So we claimed that the shelf life is 2 years.
Note: Q 10: reaction-rate coeffiecient 2.
Average Storage temperature: 20 centigrade.
Procedure: Put Vacu Lab Plain Tube and Vacu Lab Gel & Clot Activator Tube into 60 centigrade oven for 50 days, After 50 days, we collected 25 outpatient blood specimens. We drew each patient blood into viou Lab Plain Tubes, Vacu Lab Gel & Clot activator Tubes and BD vacutainer TM Plus SST Tm Tubes to compare studies. All tests were undertaken on Hitach912 and Elisa Reader TC 98. The results of comparison studies did not show any significant difference from the results of BD vacutainer TM Plus SUT Tm Tubes.
All comparison studies yield correlation coefficient ≥ 0.95. An acceptable correlation coefficient for all comparison studies is ≥ 0.95
Standard/ Guidance Document Referenced (if applicable)
NCCLS Guideline EP9-A2 -- Method Comparison and Bias Estimation Using Patient Samples. NCCLS HI-A5-Tubes and Additives for Venous Blood Specimen Collection: Anproved Standard-5 th, ed.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Jian Vaeches Official FDA Correspondent TECO Diagnostics 1268 N. Lakeview Anaheim, CA 92807
JUN 15 2006
Re: K060364
Trade/Device Name: Teco Diagnostics Vacu Lab Plain Tube and Vecu Lab Gel and Clot Activator Tube Regulation Number: 21 CFR§862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: May 30, 2006 Received: May 30, 2006
Dear Mr. Vaeches:
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 CliR 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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This letter will allow you to begin marketing your device as described in your Section 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 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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez, Ph.D.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K 060 364
Device Name: Teco Diagnostics Vacu Lab Plain Tube and Vecu Lab Gel and Clot Activator Tube
Indications For Use:
-
- The Vacu Lab Plain Tube is a sterile, plastic, evacuated blood collection tube with a silica clot activator that provides a means of collecting, transporting, separating, and processing blood in a closed tutter The specimens are used for clinical laboratory assays involving the use of patient serum.
-
- The Vacu Lab Gel & Clot Activator Tube is a sterile, plastic, evacuated blood collection tube with a silica clot activator and a barrier gel that provides a means of collecting, transporting, separating, and processing blood in a closed tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
G.C.H.
Division Sign-Off
Office of In Vitro De one alle Device Evaluation and Safety
KIDNEY
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