LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3

K032017 · Bio-Rad · GGN · Aug 8, 2003 · Hematology

Device Facts

• Record ID: K032017
• Device Name: LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
• Applicant: Bio-Rad
• Product Code: GGN · Hematology
• Decision Date: Aug 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

Liquichek™ D-dimer Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for D-dimer.

Device Story

Liquichek™ D-dimer Control is a liquid quality control product derived from processed human plasma with added constituents of human/animal origin and preservatives. It is used in clinical laboratory settings to monitor the precision of D-dimer testing procedures. The control is processed by laboratory technicians on specific coagulation analyzers (e.g., Vidas, Stratus CS, Sysmex, LIATEST, ACL, Tina-quant). By comparing the measured values of the control against established means and ranges, clinicians verify the performance and reliability of the analytical test methods. This monitoring ensures the accuracy of patient D-dimer results, which are critical for clinical decision-making regarding coagulation disorders.

Clinical Evidence

No clinical data. The device is an in vitro diagnostic quality control product; substantial equivalence is supported by bench testing, including stability studies (open vial and shelf life) and comparison of analyte levels against the predicate device.

Technological Characteristics

Liquid-form quality control consisting of processed human plasma with added human/animal constituents and preservatives. Tri-level formulation (Levels 1, 2, and 3). Storage requirements: 2°C to 8°C (unopened); 2°C to 25°C (opened).

Indications for Use

Indicated for use as an assayed quality control to monitor the precision of laboratory testing procedures for D-dimer in clinical laboratory settings.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies 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

• Liquichek™ D-dimer Control (K030182)

Submission Summary (Full Text)

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

A. 510(k) Number:
#K032017

B. Analyte:
D-Dimer

C. Type of Test:
N/A

D. Applicant:
Bio-Rad Laboratories

E. Proprietary and Established Names:
Liquichek™ D-dimer Control, Levels 1, 2 and 3

F. Regulatory Information:
1. Regulation section:
21 CFR Section 864.5425 – Multipurpose System for in vitro Coagulation Studies
2. Classification:
Class II
3. Product Code:
GGN – Coagulation Control Plasma
4. Panel:
Hematology (81)

G. Intended Use:
1. Intended use(s):
Liquichek™ D-dimer Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for D-dimer.
2. Indication(s) for use:
This control is for use with the following test methods: bioMerieux Vidas; Dade Behring Stratus CS, BCS/BCT and Sysmex Series – Advanced D-Dimer; Diagnostica Stago Sta/Sta-R/Sta-Compact – LIATEST; IL ACL Series; Roche Hitachi and Cobas Integra 400/800 – Tina-quant.
3. Special condition for use statement(s):
N/A
4. Special instrument Requirements:
Instrumentation listed under Indications for Use.

H. Device Description:
Liquichek™ D-dimer Control is a liquid coagulation control prepared from processed human plasma with added constituents of human/animal origin and preservatives.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Bio-Rad Laboratories Liquichek™ D-dimer Control, Levels 1 and 2
2. Predicate K number(s):
#K030182

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | See above | Same |
| Matrix | Liquid human plasma | Same |
| Stability | (3) years at 2° – 8° C.; (30) days at 2° – 25° C. | Same |
| Differences | | |
| Item | Device | Predicate |
| Levels | Tri-level | Bi-level |

J. Standard/Guidance Document Referenced (if applicable): N/A

K. Test Principle:
See test methods for various instruments under Indications for Use.

L. Performance Characteristics (if/when applicable):

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

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:

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M Conclusion:

This device is substantially equivalent to a legally marketed device. The sponsor provided value assignment protocols and data forms for the individual manufacturers and reference laboratories used to generate data.

They recommended at least (20) replicates for each level of quality control plasma, from separate assays over a period of (10) days, using multiple reagent lots. They required submission of the raw data obtained from the instruments used to generate the means and ranges displayed on the assay sheet.

In addition the sponsor submitted real-time stability data summaries for (3) lots of the quality control plasma. Results were within acceptable analytical limits for this kind of device.