LYPHOCHEK HEMOSTASIS CONTROL

K040275 · Bio-Rad · GGN · Feb 27, 2004 · Hematology

Device Facts

• Record ID: K040275
• Device Name: LYPHOCHEK HEMOSTASIS CONTROL
• Applicant: Bio-Rad
• Product Code: GGN · Hematology
• Decision Date: Feb 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

Lyphochek® Hemostasis Control is intended for use as an assayed quality control plasma to monitor the precision of laboratory testing procedures for analytes listed in the package insert. [See “B. Analyte(s):” above]

Device Story

Lyphochek® Hemostasis Control is a lyophilized human plasma-based quality control product used to monitor precision of hemostasis laboratory testing. It contains purified biochemicals and preservatives. The device is provided in 12 x 1ml vials across three levels. It is used by laboratory technicians in clinical settings to verify the performance of coagulation assays, including APTT, PT, AT III, TT, FIB, Protein C/S, Plasminogen, D-dimer, and various clotting factors. The control is reconstituted and processed on instruments from manufacturers such as BioMerieux, Chromogenix, Dade Behring, Diagnostica Stago, Instrumentation Laboratories/Hemoliance, and Roche. By comparing observed results against established assay values, clinicians ensure the accuracy and reliability of patient coagulation test results, supporting clinical decision-making in hemostasis management.

Clinical Evidence

No clinical data. Stability studies were performed to establish shelf life (three years at 2-8°C) and reconstituted stability (8 hours at 2-25°C, with Protein S stable for 8 hours at 2-8°C).

Technological Characteristics

Lyophilized human plasma matrix with added purified biochemicals and preservatives. Tri-level control format. Stability: 3 years at 2-8°C; 8 hours reconstituted at 2-25°C. Compatible with various coagulation instrument platforms.

Indications for Use

Indicated for use as an assayed quality control plasma to monitor precision of laboratory coagulation testing procedures. Intended for clinical laboratory use.

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

• Lyphochek Hemostasis Control (K020878)

Submission Summary (Full Text)

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

A. 510(k) Number: #K040275
B. Analyte(s): APTT, PT, AT III, TT, FIB, Protein C/S, Plasminogen, D-dimer; Factors II, V, VII, VIII, IX, X, XI and XII.
C. Type of Test: N/A
D. Applicant: Bio-Rad Laboratories
E. Proprietary and Established Names: Lyphochek® Hemostasis 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):
Lyphochek® Hemostasis Control is intended for use as an assayed quality control plasma to monitor the precision of laboratory testing procedures for analytes listed in the package insert. [See “B. Analyte(s):” above]
2. Indication(s) for use: Same as the Intended Use.
3. Special condition for use statement(s):
4. Special instrument Requirements: This quality control (QC) device has been assayed using methods/instruments by these companies: BioMerieux, Chromogenix, Dade Behring, Diagnostica Stago, Instrumentation Laboratories/Hemoliance and Roche.

H. Device Description: Lyphochek® Hemostasis Control, Levels 1, 2 and 3, is prepared from human plasma. Purified bio chemicals and preservatives are added; and the control is provided in a lyophilized form for increased stability. It is supplied in (12) x 1ml vials.

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# I. Substantial Equivalence Information:

1. Predicate device name(s): Bio-Rad Lyphochek® Hemostasis Control, Levels 1 and 2
2. Predicate K number(s): #K020878
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Assayed hemostasis QC | Same |
| Matrix | Lyophilized human plasma | Same |
| Shelf-life | (3) years at 2° - 8° C. | Same |
| Reconstituted stability | (8) hours at 2° - 25° C. | Same |
| Differences | | |
| Item | Device | Predicate |
| Assayed analytes | (17) | (16) |
| Levels | Tri-level | Bi-level |
| Additional analyte | D-dimer | None |
| | | |

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

# K. Test Principle: Various instrument/test methods under "Special Instrument Requirements" and listed on the assay sheet.

# L. Performance Characteristics (if/when applicable): N/A

1. Analytical performance:

a. Precision/Reproducibility:
b. Linearity/assay reportable range:
c. Traceability (controls, calibrators, or method):
d. Detection limit:
e. Analytical specificity:

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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:

M. Conclusion:
The device is substantially equivalent to a legally marketed device.