(61 days)
Not Found
No
The device is a laboratory control plasma used for quality assurance of coagulation tests. The description focuses on its composition and performance characteristics, with no mention of AI or ML.
No.
The device is described as a control plasma used in a laboratory for quality assurance of PT and APTT results, not for treating a disease or condition.
No
This device is a control plasma used for quality assurance in laboratory testing of activated partial thromboplastin time (APTT) and prothrombin time (PT), not a diagnostic device itself. It helps verify the performance of diagnostic tests but does not directly diagnose a patient's condition.
No
The device description clearly states it is a "lyophilized preparation of fresh human citrated plasma with added stabilizers and buffers," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use in a "laboratory program of quality assurance for activated partial thromboplastin time (APTT) and prothrombin time (PT) results". These are laboratory tests performed on biological samples (plasma) to diagnose or monitor medical conditions.
- Device Description: It is a "lyophilized preparation of fresh human citrated plasma with added stabilizers and buffers". This is a reagent used in laboratory testing.
- Function: It is used to "verify the lower extent of the reportable range of the PT and APTT" and "provides a means for verifying the lower extent of the reportable range of the PT and APTT". This is a quality control material used in diagnostic testing.
- User: The intended user is a "laboratory program".
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
N/A
Intended Use / Indications for Use
Control Level 0 Plasma is intended for use in a laboratory program of quality assurance for activated partial thromboplastin time (APTT) and prothrombin time (PT) results with short clotting times. PT and APTT clotting times at the low end, or below the locally determined normal reference range are often related to the presence of elevated levels of fibrinogen and factor VIII. Both of these proteins are elevated in response to an inflammatory stimulus, malignant disease process or trauma. Control Level 6 Plasma provides a means for verifying the lower extent of the reportable range of the PT and APTT, particularly the imprecision of short clotting times often encountered with these screening tests.
Product codes (comma separated list FDA assigned to the subject device)
GGN
Device Description
Control Level 6 Plasma is a lyophilized preparation of fresh human citrated plasma with added stabilizers and buffers. The reconstitution volume is 1.0 mL (with deionized or distilled water). Control Level Theta contains markedly elevated levels of human fibrinogen and factor VIII, and produces an abnormally short Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) with a variety of end-point detection methods. Each unit of source material used in the preparation of this product has been tested by an FDA approved method and found non-reactive for HBAg (Hepatitis B Surface antigen) and negative for antibodies to HIV and HCV. However, since no known test method can offer complete assurance that product derived from human blood will not transmit Hepatitis, AIDS, or other infectious diseases, this product should be handled as potentially infectious biological material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Within-run precision studies performed on two different instruments (MLA-1000CTM & MLA-1600) using both Dade and Pacific Hemostasis brand PT and APTT reagents yielded comparable data. The coefficient of variation (CV) for Control Level Theta and Dade® Ci-Trol® I was well below the performance specifications. (For Pacific Hemostasis Control Level Theta the CV for both PT and APTT must be ≤ 5%. The stated CV for Dade® Ci-Trol® I is ≤ 5% and
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
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.(b)
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.
0
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PREMARKET NOTIFICATION 510(K) SUMMARY
| Submitter: | Laura A. Worfolk, Ph.D.
Pacific Hemostasis
11515 Vanstory Drive
Huntersville, NC 28078
(704) 875-0494
Fax # (704) 875-6671 |
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
The same as above. Contact Person:
4/16/97 Date:
Coagulation Control Plasma (Abnormal) Level 6 Trade Name:
Not applicable Common Name:
Classification Name: Plasma, Coagulation Control (per 21 CFR section 864.5425)
Dade® Ci-Trol® Coagulation Control, Level I Equivalent Device:
Description of Coagulation Control Plasma (Abnormal) Level θ:
Control Level 6 Plasma is a lyophilized preparation of fresh human citrated plasma with added stabilizers and buffers. The reconstitution volume is 1.0 mL (with deionized or distilled water). Control Level Theta contains markedly elevated levels of human fibrinogen and factor VIII, and produces an abnormally short Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) with a variety of end-point detection methods. Each unit of source material used in the preparation of this product has been tested by an FDA approved method and found non-reactive for HBAg (Hepatitis B Surface antigen) and negative for antibodies to HIV and HCV. However, since no known test method can offer complete assurance that product derived from human blood will not transmit
1
Hepatitis, AIDS, or other infectious diseases, this product should be handled as potentially infectious biological material.
Intended Use of Coagulation Control Plasma (Abnormal) Level 9:
Control Level 0 Plasma is intended for use in a laboratory program of quality assurance for activated partial thromboplastin time (APTT) and prothrombin time (PT) results with short clotting times. PT and APTT clotting times at the low end, or below the locally determined normal reference range are often related to the presence of elevated levels of fibrinogen and factor VIII. Both of these proteins are elevated in response to an inflammatory stimulus, malignant disease process or trauma. Control Level 6 Plasma provides a means for verifying the lower extent of the reportable range of the PT and APTT, particularly the imprecision of short clotting times often encountered with these screening tests.
Summary of Data Comparing Control Level 8 Plasma to Dade® Ci-Trol® Level I:
Pacific Hemostasis Control Level Theta was compared to Dade® Ci-Trol® Level I. a pre-amendment device. Both Control Level Theta and Dade® Ci-Trol® Level I plasmas are lyophilized preparations of human citrated plasmas with added stabilizers and buffers. The intended use for both products is indistinguishable: as a control plasma for Prothrombin and Activated Partial Thromboplastin Time testing in a clinical laboratory program of quality assurance. Control Level Theta contains elevated levels of human fibrinogen and Factor VIII. which result in clotting times below the normal reference range. In contrast, Dade® Ci-Trol® Level I yields clotting times within the normal reference range.
Within-run precision studies performed on two different instruments (MLA®-1000C™ & MLA®-1600) using both Dade and Pacific Hemostasis brand PT and APTT reagents yielded comparable data. The coefficient of variation (CV) for Control Level Theta and Dade® Ci-Trol® I was well below the
2
performance specifications. (For Pacific Hemostasis Control Level Theta the CV for both PT and APTT must be ≤ 5%. The stated CV for Dade® Ci-Trol® I is ≤ 5% and Veronica Celuia for Dr. Montgomery (Division Sign-Off) |
|-----------------------------------------|---------------------------------------------------------------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | 0971428 |
| scription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| r 21 CFR 801.109) | (Optional Format 1-2-96) |