(202 days)
Not Found
No
The device is a blood collection tube and the description and performance studies focus on its physical properties and ability to collect and preserve blood samples for laboratory analysis. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as being for "in vitro diagnostic use" to collect, transport, separate, and process blood specimens for clinical chemistry and immunology assays, not for treatment.
No
This device is a blood collection tube used to prepare samples for diagnostic assays, but it is not itself a diagnostic device that performs the assay or provides a diagnosis. Its intended use states it is "For in vitro diagnostic use", meaning the samples it prepares are used for diagnostics, not that the tube itself is a diagnostic device.
No
The device description clearly states it is a sterile, plastic, evacuated blood collection tube consisting of physical components (closure assembly, silica clot activator, Barrier Gel, plastic tube). This is a hardware device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
Furthermore, the device is used to collect, transport, separate, and process venous blood specimens to obtain serum for clinical chemistry and immunology assays, which are all activities performed in a laboratory setting for diagnostic purposes.
N/A
Intended Use / Indications for Use
IMPROVACUTER Gel & Clot Activator Tube is a single used to collect, transport, separate, and process venous blood specimens to obtain serum for clinical chemistry and immunology assays. It is used in settings where a venous blood sample is collected by a trained healthcare worker. For in vitro diagnostic use.
Product codes
JKA
Device Description
The IMPROVACUTER® 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 plastic tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
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
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Intended User / Care Setting
It is used in settings where a venous blood sample is collected by a trained healthcare worker.
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)
Method Comparison Studies: Clinical evaluations were performed to determine the safety and efficiency of the IMPROVACUTER® Gel & Clot Activator Tube. The devices were compared to the prodicate BD Vacutainer® tubes in total 28 chemistry assays and 13 Immunology assays. The clinical evaluation demonstrated that the IMPROVACUTER® Gel & Clot Activator Tube provide clinically equivalent chemistry analyte results when compared to the BD Vacutainer® tubes. All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.
Stability Studies: Studies were conducted to compare fresh specimens.24 hours stored both at 2-8℃ and at 22-25°C. All results showed no significant different from BD Vacutainer® stored under the same condition. Analyte stability testing has been conducted for all the analytes listed. Stability for 24 hours at room temperature and refrigerated temperature has been demonstrated for all the analytes except TBIL. TBIL is stable at room temperature for up to 20 hours. All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.
Shelf-life Studies: The shelf life studics are to research whether the IMPROVACUTER® Gel & Clot Activator Tube have significant difference from the ones which had just been manufactured. All results showed no significant different from these. All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.
Same-Lot Repeatability Study: This test is intended to test IMPROVACUTER® Gel & Clot Activator Tube. whose lots are the same to those of products used in Method Comparison Study. Compare the test results with those of Method Comparison Study to determine whether there are major differences. All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.
Lot-to-Lot Reproducibility Study: Select 2 lots from both materials of normally produced IMPROVACUTER® Gel & Clot Activator Tube, and compare the test results with those of Method Comparison Study to determine whether there are major differences. All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Figure/1 description: The image contains a logo for "IMPROVE MEDICAL" in black font. The logo includes a stylized graphic element to the left of the text. To the right of the logo, there is a table with the word "Gua" at the top and the number "510" below it.
Guangzhou Improve Medical Instruments Co., Ltd. 510 (K) Submission for IMPROVACUTER* Evacuated Blood Collection Tubes
Attachment V 510(K) Summary
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 510(k) Number is: K093910
Date Prepared: 05 JUL 2010
1. Sponsor Information
Guangzhou Improve Medical Instruments Co., Ltd. No.102 Kaiyuan Road, Guangzhou Science Park Hi-Tech Industries Development Zone Guangzhou City, Guangdong, China 510663 Tel: +86-20-8158 5255 Fax: +86-20-8158 7533 http://www.improve-medical.com Contact Person: Bonford Sun, Quality Manager Email: qd9@improve-medical.com
- Submission Correspondent
Ms. Diana Hong, General Manager Shanghai Mid-Link Business Consulting Co., Ltd Suite 5D, No.19, Zhongshan Road (S-2) Shanghai, 200030, China.
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Image /page/1/Figure/0 description: The image shows a logo with the word "IMPROVE" in bold, italicized letters. To the right of the word "IMPROVE" is a graphic. Below the graphic and to the right of the word "IMPROVE" is the text "IMPROVE MEDICAL". The text is in a smaller font than the word "IMPROVE".
Guangzhou Improve Medical Instruments Co., Ltd.
510 (K) Submission for IMPROVACUTER " Evacuated Blood Collection Tubes
3. Proposed Device Identification
Devicc Name: IMPROVACUTER® Gel & Clot Activator Tube Specifications: 13 x 75 mm / 13 x 100 mm Draw Volume: 3-5 ml for both specifications Classification Name Classification: Class II Product Code: JKA Regulation Number: 21 CFR. 862.1675
4. Device Description
The IMPROVACUTER® 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 plastic tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
5. Intended Use
IMPROVACUTER Gel & Clot Activator Tube is a single used to collect, transport, separate, and process venous blood specimens to obtain serum for clinical chemistry and immunology assays. It is used in settings where a venous blood sample is collected by a trained healtheare worker. For in vitro diagnostic use.
6. Predicate Device Identification
BD Vacutainer® Gel & Clot Activator Tube (plastic) 510(k) Number: K023075.
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IMPROVE IMPROVE MEDICAL
Guangzhou Improve Medical Instruments Co., Ltd. 510 (K) Submission for IMPROVACUTER® Evacuated Blood Collection Tubes
7. Substantial Equivalence
Based on a comparison of the features, materials and intended use, the IMPROVACUTER® Gel & Clot Activator Tube are substantially equivalence to the commercially available predicate devices. The only difference between the predicate and the IMPROVACUTER® Gel & Clot Activator Tube is the performance claim not for Therapeutic Drug Monitoring (TDM). SE comparison information is presented below:
| ITEM | Proposed Device | Predicate Device |
|---|---|---|
| IMPROVACUTER® Gel & Clot | ||
| Activator Tube | BD Vacutainer® Gel & Clot Activator | |
| Tube (plastic) | ||
| K023075 | ||
| Intended Use | IMPROVACUTER Gel & Clot | |
| Activator Tube is a single use tube | ||
| used to collect, transport, separate, and | ||
| process venous blood specimens to | ||
| obtain serum for clinical chemistry | ||
| and immunology assays. It is used in | ||
| settings where a venous blood sample | ||
| is collected by a trained healthcare | ||
| worker. For in vitro diagnostic use. | The BD Vacutainer® Tube is a evacuated | |
| blood collection tube that provides a | ||
| means of collecting, transporting, | ||
| separating, and processing blood in a | ||
| closed tube. Blood collected in a | ||
| Vacutainer® Tube is primarily used for | ||
| clinical laboratory testing in chemistry | ||
| using patient serum, but may be used for | ||
| other assays requiring serum specimens as | ||
| determined by the laboratory. In addition, | ||
| the Vacutainer® Tube is compatible with | ||
| many commonly used therapeutic drugs | ||
| therefore suitable for therapeutic drug | ||
| monitoring (TDM). | ||
| Tube Dimension | 13 x 75 mm | |
| 13 x 100 mm | 13 x 75 mm | |
| Draw Volume | 3-5 ml | 3.5 ml |
| Closure | Conventional Rubber Closure | SAME |
| Clot Activator | Silica | SAME |
| Tube Shelf Life | 12 months | SAME |
| Sterility | Sterilized | SAME |
| Package | Plastic film barrier bag in cardboard | |
| shelf carton. | SAME |
Table 7-1 Similarities and differences table between your predicate and your candidate devices
3
Image /page/3/Figure/0 description: The image contains the logo for Improve Medical. The logo includes the text "IMPROVE" in bold, along with Chinese characters and the text "IMPROVE MEDICAL". To the right of the logo is the text "Guang" and "510 (K) S".
Guangzhou Improve Medical Instruments Co., Ltd. 510 (K) Submission for IMPROVACUTER Evacuated Blood Collection Tubes
8. Synopsis of Test Methods and Results
Method Comparison Studies
Clinical evaluations were performed to determine the safety and efficiency of the IMPROVACUTER® Gel & Clot Activator Tube. The devices were compared to the prodicate BD Vacutainer® tubes in total 28 chemistry assays and 13 Immunology assays. The clinical evaluation demonstrated that the IMPROVACUTER® Gel & Clot Activator Tube provide clinically equivalent chemistry analyte results when compared to the BD Vacutainer® tubes.
All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.
Stability Studies
Studies were conducted to compare fresh specimens.24 hours stored both at 2-8℃ and at 22-25°C. All results showed no significant different from BD Vacutainer® stored under the same condition.
Analyte stability testing has been conducted for all the analytes listed. Stability for 24 hours at room temperature and refrigerated temperature has been demonstrated for all the analytes except TBIL. TBIL is stable at room temperature for up to 20 hours.
All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.
Shelf- life Studies
The shelf life studics are to research whether the IMPROVACUTER® Gel & Clot Activator Tube have significant difference from the ones which had just been manufactured. All results showed no significant different from these.
All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.
Same-Lot Repeatability Study
This test is intended to test IMPROVACUTER® Gel & Clot Activator Tube. whose lots are the same to those of products used in Method Comparison Study. Compare the test results with those of Method Comparison Study to determine whether there are major differences.
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Image /page/4/Picture/15 description: The image shows a logo with the word "IMPROVE" in bold, italicized letters. To the right of the word is a symbol and the Chinese characters for "Yangsen Medical". Below the Chinese characters are the words "IMPROVE MEDICAL" in smaller, non-italicized letters. The logo appears to be for a medical company.
Guangzhou Improve Medical Instruments Co., Ltd.
510 (K) Submission for IMPROVACUTER* Evacuated Blood Collection Tubes
All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.
Lot-to-Lot Reproducibility Study
Select 2 lots from both materials of normally produced IMPROVACUTER® Gel & Clot Activator Tube, and compare the test results with those of Method Comparison Study to determine whether there are major differences.
All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.
Standard/ Guidance Document Referenced
- ア CLSI Guideline, EP9-A2: Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline Second edition.
- ア CLSI H18-A3: Procedures for the Handling and Processing of Blood Specimens; Approved Guideline
- ﺮ CLSI H1-A5: Evacuated Tubes and Additives for Blood Specimen Collection, Approved Standard -Fifth Edition
- ﺮ CLSI H3-A6: Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture, Approved Standard -Fifth Edition
- V ANSI/AAMI/ISO 11137: Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Guangzhou Improve Medical Instruments Co., Ltd. c/o Ms. Diana Hong General Manager Shanghai Midlink Business Consulting Co., Ltd. Suite 5D, No. 19, Lane 999, Zhongshan No. 2 Road (S) Shanghai, China 200030
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
JUL 1 2 2010
Re: K093910
.
Trade Name: IMPROVACUTER® Gel & Clot Activator Tube Regulation Number: 21 CFR §862.1675 Regulation Name: Blood specimen collection devices Regulatory Class: Class II Product Codes: JKA Dated: July 05, 2010 Received: July 07, 2010
Dear Ms. Hong:
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 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820),
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, 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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Image /page/7/Picture/0 description: The image shows the logo for Improve Medical. The logo includes a stylized image of a bird, along with the word "IMPROVE" in bold letters. To the right of the bird image, there are Chinese characters and the words "IMPROVE MEDICAL".
Guangzhou Improve Medical Instruments Co., Ltd.
510 (K) Submission for IMPROVACUTER® Evacuated Blood Collection Tubes
Attachment I Indication for Use
510(k) Number: K093910 Device Name: IMPROVACUTER® Gel & Clot Activator Tube
Indication for Use:
IMPROVACUTER Gel & Clot Activator Tube is a single used to collect, transport, separate, and process venous blood specimens to obtain serum for clinical chemistry and immunology assays. It is used in settings where a venous blood sample is collected by a trained healthcare worker.
For in vitro diagnostic use.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
CARS
Division Sign-
Office of In Vitro Dia Device
510(k) K093910
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