← Product Code [GGN](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN) · K040275

# LYPHOCHEK HEMOSTASIS CONTROL (K040275)

_Bio-Rad · GGN · Feb 27, 2004 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K040275

## Device Facts

- **Applicant:** Bio-Rad
- **Product Code:** [GGN](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN.md)
- **Decision Date:** Feb 27, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5425
- **Device Class:** Class 2
- **Review Panel:** Hematology

## 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.

## Regulatory 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](/device/K020878.md))

## 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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Page 3 of 3

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.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K040275](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K040275)

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