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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Required Performance)	Reported Device Performance (Teco Tubes vs. Predicate)
Correlation coefficient (r) ≥ 0.95 for all comparative studies of chemistry analytes.	All comparison studies yielded a correlation coefficient ≥ 0.95.
Equivalent results to predicate device for specific chemistry analytes (e.g., total protein, albumin, bilirubin, AST, ALT, ALP, r-GT, cholesterol, potassium, glucose, creatinine, etc.).	The Vacu Lab Plain Tube demonstrated equivalent results to the predicate device for all tested analytes.
No significant difference from fresh specimens and 72-hour stored specimens at 2-8℃.	All results showed no significant difference from fresh specimens and 72 hours stored at 2-8℃.
Shelf-life of at least 24 months (2 years).	The shelf life was claimed to be 2 years based on accelerated aging studies.
No significant difference in results after accelerated aging (equivalent to 2 years real-time).	The results of comparison studies after accelerated aging did not show any significant difference from the results of the BD Vacutainer™ Plus SST™ Tubes.

2. Sample Size Used for the Test Set and Data Provenance

Study I (Vacu Lab Plain Tube): 66 paired samples from outpatients. The country of origin is not explicitly stated, but the company is based in the USA, suggesting US patients. The study is prospective in nature as samples were collected specifically for this evaluation.
Study II (Vacu Lab Plain Tube): 25 randomly collected outpatient blood samples. The country of origin is not explicitly stated. The study is prospective.
Study III (Vacu Lab Gel & Clot Activator Tube): 70 paired samples from outpatients. The country of origin is not explicitly stated. The study is prospective.
Study IV (Vacu Lab Gel & Clot Activator Tube): 25 randomly collected outpatient blood samples. The country of origin is not explicitly stated. The study is prospective.
Stability Studies: Not specified, but involved comparing "fresh specimens" to "72 hours stored at 2-8℃" specimens. Likely a subset of the clinical samples.
Shelf-life Studies: 25 outpatient blood specimens were collected after the devices underwent accelerated aging. The country of origin is not explicitly stated. The study is prospective for data collection post-aging.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the studies are method comparison studies for blood collection devices. The "ground truth" is established by comparing the results obtained from the new device (Teco tubes) against a legally marketed predicate device (BD Vacutainer™ Plus SST™ Tube), which is assumed to provide accurate results for the chemistry analytes. There are no human experts establishing a "ground truth" diagnosis in this context; rather, the performance is assessed against an established analytical method.

4. Adjudication Method for the Test Set

This is not applicable for this type of device and study. Adjudication refers to resolving disagreements among multiple expert readers in diagnostic studies. Here, the comparison is analytical, between two types of blood collection tubes measured by automated chemistry analyzers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. This document describes the evaluation of blood collection tubes, not an AI-powered diagnostic device or a system involving human readers interpreting results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This device is a blood collection tube, which is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in these studies is implicitly defined by the results obtained from the legally marketed predicate device (BD Vacutainer™ Plus SST™ Tube). The Teco tubes are compared against this established product using standard clinical laboratory chemistry assays. The goal is to demonstrate "substantial equivalence" in analytical performance.

8. The Sample Size for the Training Set

This is not applicable. As these are blood collection tubes being physically evaluated, there is no "training set" in the context of machine learning or AI models. The studies described are clinical performance evaluations.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated in point 8.

Summary

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K060364

TECO DIAGNOSTICS

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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 TubeVacu 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

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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;

1. 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.
1. 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

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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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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:

1. 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.
1. 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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Regulation Number and Section

§ 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.