LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743

K032611 · Bio-Rad · GGN · Sep 17, 2003 · Hematology

Device Facts

• Record ID: K032611
• Device Name: LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
• Applicant: Bio-Rad
• Product Code: GGN · Hematology
• Decision Date: Sep 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

Lyphochek® Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.

Device Story

Lyphochek® Coagulation Control Level 4 is a lyophilized human plasma-based quality control material containing added purified biochemicals of animal origin and preservatives. It is used by laboratory personnel to monitor the precision of citrated coagulation systems. The control is reconstituted and analyzed alongside patient samples to verify the performance of coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, Antithrombin III (AT III), and Thrombin Time (TT). By comparing observed results against established target values, clinicians ensure the accuracy and reliability of coagulation testing, which is critical for diagnosing and managing bleeding or clotting disorders.

Clinical Evidence

Bench testing only. Stability studies confirmed open-vial stability of 24 hours at 2-25°C and a shelf life of three years when stored at 2-8°C.

Technological Characteristics

Lyophilized human plasma matrix; contains purified biochemicals of animal origin and preservatives. Form factor: 1 mL fill size. Storage: 2-8°C. Stability: 24 hours open-vial at 2-25°C. Analyte panel: PT, APTT, Fibrinogen, AT III, TT.

Indications for Use

Indicated for use as a quality control plasma to monitor the precision of citrated coagulation systems 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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K032611

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the addition of a single control (Level 4) to the manufacturer's current tri-level control (Level 1, 2, and 3) product.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability. The difference is in the formulation. The new single control (Level 4) contains added constituents of animal origin and the current tri-level does not. In addition, Level 4 does not include Levels 1, 2, and 3 and the tri-level does not include Level 4.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

(Reviewer's Signature)

(Date)

Comments

This is a low risk device. The manufacturer developed target values. Examples of protocol sheets and data collection forms sent to reference laboratories and value assignment facilities for data generation were provided. However, the labeling clearly states that users are encouraged to establish their own parameters of precision.

Revised: 3/27/98