(50 days)
Not Found
No
The summary describes a control plasma for heparin assays and APTT testing. There is no mention of AI, ML, or any computational analysis of data that would suggest the use of these technologies. The performance studies focus on precision (CV), which is a standard metric for laboratory controls, not AI/ML performance.
No.
This device is an unassayed control plasma intended for use in heparin assay procedures and for quality control in monitoring heparin therapy with APTT testing, rather than directly treating a condition or disease.
No
Explanation: This device is described as an "unassayed control plasma" intended for "quality control in monitoring heparin therapy." It is used to monitor the performance of assays (like APTT testing) rather than directly diagnosing a patient's condition.
No
The device description clearly states it is a lyophilized preparation of citrated plasma, which 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 heparin assay procedures" and "for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing." These are laboratory tests performed on biological samples (plasma) outside of the body to provide information about a person's health status or to monitor treatment.
- Device Description: It's a "lyophilized preparation of citrated plasma obtained from healthy donors," which is a biological material used in laboratory testing.
- Performance Studies: The performance studies describe precision testing (between-run and within-run CV) for APTT, which is a common metric for evaluating the performance of IVD devices used in coagulation testing.
- Predicate Device: The mention of a predicate device (Dade Ci-Trol Heparin Control Low) with a K number (K771346) indicates that this device is being compared to a previously cleared IVD device.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Pacific Hemostasis Heparin Control Level 1, an unassayed control plasma, is intended for use in heparin assay procedures. In addition, it can be used for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing. It will yield APTT values in the slightly abnormal range.
Product codes
GGN
Device Description
Pacific Hemostasis Heparin Control Level 1 is a lyophilized preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found nonreactive for HBsAG and negative for antibodies to HIV and HCV.
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)
Between-run and within-run precision studies yielded equivalent data for Pacific Hemostasis and Dade Brand Coagulation Heparin control plasmas. For both controls a CV of less than 2.0% was obtained for APTT between-run testing, and less than 1.0% for within-run testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
AUG 26 1999
PREMARKET NOTIFICATION 510(k) SUMMARY 7.0
| Applicant:
Address: | Laura A. Worfolk, Ph.D.
Pacific Hemostasis
11515 Vanstory Drive
Huntersville, NC 28078 |
|------------------------|-------------------------------------------------------------------------------------------------|
| Phone: | (800) 528-0494 or (704) 875-0494 |
| Fax: | (704) 875-2092 |
| Contact Person: | Same as above. |
| Date: | July 6, 1999 |
| Trade Name: | Heparin Control Plasma Level 1 |
| Common Name: | Heparin Control Plasma Level 1 |
| Classification Name: | Plasma, Coagulation Control |
| Equivalent Device: | Dade Ci-Trol Heparin Control Low, K771346 |
Description of Heparin Control Level 1
Pacific Hemostasis Heparin Control Level 1 is a lyophilized preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found nonreactive for HBsAG and negative for antibodies to HIV and HCV.
Intended Use of Heparin Control Level 1
Pacific Hemostasis Heparin Control Level 1, an unassayed control plasma, is intended for use in heparin assay procedures. In addition, it can be used for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing. It will yield APTT values in the slightly abnormal range.
Summary of Performance Data for Substantial Equivalence Comparisons
Between-run and within-run precision studies yielded equivalent data for Pacific Hemostasis and Dade Brand Coagulation Heparin control plasmas. For both controls a CV of less than 2.0% was obtained for APTT between-run testing, and less than 1.0% for within-run testing.
Based on the data provided, the similar.composition and intended use, it is our conclusion that these two products are substantially equivalent.
Page 9 of 16
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 26 1999
Laura A. Worfolk, Ph.D. Research Scientist Pacific Hemostasis 11515 Vanstory Drive Suite 125 Huntersville, North Carolina 28078-8144
Re: K992278 Trade Name: Heparin Control Plasma Level 1 Regulatory Class: II Product Code: GGN Dated: August 10, 1999 Received: August 11, 1999
Dear Dr. Worfolk:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT OF INDICATIONS FOR USE
Pacific Hemostasis Heparin Control Plasma Level 1, an unassayed control plasma, is intended for use as a control in heparin assay procedures.
Peter E. Maher
(Division Sign-Off) Division of Clinical Laboratory Devices 992278 510(k) Numl
ទ្រព្យ របស់ : ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------
078407 HMC00 / V
Prescription
Use. ✓