METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK

K042336 · Bio-Rad Laboratories, Inc. · JPK · Oct 14, 2004 · Hematology

Device Facts

• Record ID: K042336
• Device Name: METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: JPK · Hematology
• Decision Date: Oct 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Indications for Use

Meter Trax is an assayed whole blood control used in monitoring the precision of laboratory testing procedures for hemoglobin, hematocrit and glucose.

Device Story

Meter Trax is a tri-level (low, medium, high) liquid control; consists of stabilized human red blood cell components, animal-derived constituents, chemicals, stabilizers, and preservatives. Used in clinical laboratory settings to monitor precision of testing procedures for hemoglobin, hematocrit, and glucose. Healthcare providers use the control to verify instrument performance and ensure accuracy of patient test results.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed open-vial stability (31 days at 2-8°C for hematocrit; 31 days at 2-8°C or 18-30°C for glucose and hemoglobin) and shelf-life stability (180 days at 2-8°C).

Technological Characteristics

Tri-level liquid suspension; human red blood cell components; includes chemical stabilizers and preservatives. No specific ASTM standards cited. Standalone control product.

Indications for Use

Indicated for use as an assayed whole blood control to monitor the precision of laboratory testing procedures for glucose, hemoglobin, and hematocrit.

Regulatory Classification

Identification

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

Special Controls

*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Meter Trax (K904461)

Submission Summary (Full Text)

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

A. 510(k) Number:
K042336

B. Purpose for Submission:
To seek clearance of a new whole blood hematology/glucose control.

C. Measurand:
Hemoglobin, hematocrit and glucose

D. Type of Test:
Assayed whole blood control

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Meter Trax Control

G. Regulatory Information:
1. Regulation section:
21 CFR 864.8625
21 CFR 862.1660
2. Classification:
Class II
3. Product code:
JPK
JJY

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4. Panel:
81 Hematology

H. Intended Use:

1. Intended use(s):
Meter Trax is an assayed whole blood control used in monitoring the precision of laboratory testing procedures for hemoglobin, hematocrit and glucose.

2. Indication(s) for use:

3. Special conditions for use statement(s):

4. Special instrument requirements:

I. Device Description:
Meter Trax is a tri-level (low, medium, high) liquid suspension of stabilized human red blood cell components with added constituents of animal origin, chemicals, stabilizers, and preservatives.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Meter Trax
Bio-Rad Laboratories (formerly Hematronix, Inc.)

2. Predicate 510(k) number(s):
K904461

3. Comparison with predicate:

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Matrix | Human whole blood based | same |
| Form | Liquid | same |
| Analytes | Hemoglobin, hematocrit, glucose | same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | Meter Trax is an assayed whole blood control intended for use in monitoring the precision of laboratory testing procedures for glucose, hemoglobin, and hematocrit. | Meter Trax™ is intended for use as a whole blood reference control for glucose, hemoglobin, and hematocrit. |
| Stabilizers | Contains stabilizers | Does not contain stabilizers |

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

# L. Test Principle:

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

1. Analytical performance:

a. Precision/Reproducibility:
b. Linearity/assay reportable range:
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
d. Detection limit:
e. Analytical specificity:
f. Assay cut-off:

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2. Comparison studies:
a. Method comparison with predicate device:
b. Matrix comparison:

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

4. Clinical cut-off:

5. Expected values/Reference range:

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.