VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE

K060364 · Teco Diagnostics · JKA · Jun 15, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060364
• Device Name: VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE
• Applicant: Teco Diagnostics
• Product Code: JKA · Clinical Chemistry
• Decision Date: Jun 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended 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 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.

Device Story

Teco Blood Specimen Collection Devices consist of sterile, evacuated plastic tubes used for venous blood collection. The Vacu Lab Plain Tube contains a silica clot activator and silicone surfactant coating; the Vacu Lab Gel & Clot Activator Tube adds a barrier gel. Used in clinical settings by healthcare personnel to collect and transport blood samples. Following collection, tubes are centrifuged to separate serum from cellular components. The resulting serum is used for various clinical chemistry assays. The closed system design facilitates safe handling and processing. The device benefits patients by providing a standardized, stable medium for serum-based diagnostic testing, ensuring sample integrity for laboratory analysis.

Clinical Evidence

Bench testing only. Method comparison study performed comparing subject tubes to predicate using blood samples analyzed for 27 clinical chemistry analytes (e.g., total protein, albumin, electrolytes, enzymes, hormones). Linear regression analysis demonstrated r² ≥ 0.95 for all analytes, meeting acceptance criteria.

Technological Characteristics

Sterile, plastic, evacuated tubes. Components: closure assembly, silica clot activator, silicone surfactant coating, inert polyester barrier gel (Gel tube only). Radiation sterilization per ANSI/AAMI/ISO 11137. Compliant with CLSI H18-A, H1-A5, and H3-A5 standards.

Indications for Use

Indicated for the collection, transport, separation, and processing of venous blood in a closed system for clinical laboratory assays requiring serum specimens. Intended for use by healthcare professionals in clinical settings.

Regulatory Classification

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.

Predicate Devices

• BD Vacutainer Plus SST Tube (K023075)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k060364

B. Purpose for Submission:
New device

C. Measurand:
Not applicable (devices may be used to collect blood samples for many different assays)

D. Type of Test:
Not applicable

E. Applicant:
Teco Diagnostics

F. Proprietary and Established Names:
Teco Diagnostics Vacu Lab Plain Tube
Teco Diagnostics Vacu Lab Gel and Clot Activator Tube

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1675
2. Classification:
Class II
3. Product code:
JKA

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4. Panel:
75 (Clinical Chemistry)

H. Intended Use:

1. Intended use(s):
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.

2. Indication(s) for use:
Refer to intended use above

3. Special conditions for use statement(s):
Prescription Use only.

These blood collection tubes are not intended to be used to collect blood specimens for therapeutic drug monitoring.

4. Special instrument requirements:
Not applicable

I. Device Description:
The Teco Diagnostics Vacu Lab Plain Tube is a sterile, plastic, evacuated blood collection tube. It consists of a closure assembly, a silica clot activator, and a silicone surfactant coated on the inside of the plastic tube. The Teco Diagnostics Vacu Lab Gel and Clot Activator Tube is identical to the Plain Tube except for the addition of a barrier gel that separates the serum from the cells when centrifuged.

J. Substantial Equivalence Information:

1. Predicate device name(s):

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BD Vacutainer Plus SST Serum Separator Tube

2. Predicate 510(k) number(s):

k023075

3. Comparison with predicate:

| Similarities | | | |
| --- | --- | --- | --- |
| Item | Plain Tube | Gel Separator Tube | Predicate |
| Components | Same, except no gel barrier | Same | closure assembly, inert polyester gel barrier, silica clot activator, silicone surfactant coated plastic tube |
| Matrix | Same | Same | Serum |
| Analytes | Same | Same | General Clinical Chemistry Analytes |
| Differences | | | |
| --- | --- | --- | --- |
| Item | Plain Tube | Gel Separator Tube | Predicate |
| Therapeutic Drug Monitoring (TDM) | Not intended for use with TDM samples | Not intended for use with TDM samples | May be used for TDM samples |

## K. Standard/Guidance Document Referenced (if applicable):

CLSI (formerly NCCLS) H18-A: Procedures for the Handling and Processing of Blood Specimens; Approved Guideline

CLSI (formerly NCCLS) H1-A5: Evacuated Tubes and Additives for Blood Specimen Collection, Approved Standard – Fifth Edition

CLSI (formerly NCCLS) H3-A5: Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture, Approved Standard – Fifth Edition

ANSI/AAMI/ISO 11137: Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization

## L. Test Principle:

Not applicable.

## M. Performance Characteristics (if/when applicable):

1. Analytical performance:

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a. Precision/Reproducibility:

Not applicable.

b. Linearity/assay reportable range:

Not applicable.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Not applicable.

d. Detection limit:

Not applicable.

e. Analytical specificity:

Not applicable.

f. Assay cut-off:

Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:

To demonstrate comparable performance with the predicate device, the sponsor collected blood samples into the Plain Tube, the Gel and Clot Activator Tube, and the predicate tube. The specimens were allowed to clot, and the serum was removed for testing immediately after centrifugation. Serum from the three tubes was then tested on two different analyzers for total protein, albumin, total bilirubin, direct bilirubin, AST, ALT, ALP, r-GT, cholesterol, potassium, glucose, creatinine, calcium, chloride, creatine kinase, hCG, magnesium, phosphorous, triglyceride, uric acid, BUN, sodium, CK-MB, TSH, free T4, ferritin, and prolactin. The sponsor's acceptance criterion was that the $r^2$ value from linear regression be $\geq 0.95$. Linear regression was performed using the predicate (independent variable) vs. the Plain Tube (dependent variable) and the predicate (independent variable) vs. the Gel and Clot Activator Tube (dependent variable). All of the comparisons met the acceptance criteria.

b. Matrix comparison:

Not applicable. These blood collection tubes are for serum only.

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3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Not applicable.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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