(13 days)
Not Found
No
The device description and performance studies focus on the chemical properties and precision of a coagulation control, with no mention of AI or ML algorithms for analysis or interpretation.
No
This device is a control to monitor the performance of PT and APTT testing, not for direct therapeutic use on a patient.
No
This device is a control used to monitor the performance of diagnostic tests (PT and APTT testing), not a diagnostic device itself.
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 that it is "intended for use as a control to monitor the performance of Prothrombin Time (PT) and Activated Partial Time (APTT) testing." This indicates it is used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description details a "lyophilized preparation of citrated plasma" and how it is used to "yield prolonged Prothrombin Time and Activated Partial Thromboplastin Time values." This further confirms its use as a reagent or control in laboratory testing.
- Performance Studies: The document describes "Between-run and within-run precision studies" and reports "CV%" as a key metric. These are typical performance characteristics evaluated for IVD controls.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K771346) is a strong indicator 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 Coagulation Control Level 3 is intended for use as a control to monitor the performance of Prothrombin Time (PT) and Activated Partial Time (APTT) testing. It will yield PT and APTT values in the markedly abnormal range.
Product codes (comma separated list FDA assigned to the subject device)
GGC
Device Description
Pacific Hemostasis Coagulation Control Level 3 (Abnormal) is a lyophilized preparation of citrated plasma obtained from healthy donors, which has been adjusted to yield prolonged Prothrombin Time and Activated Partial Thromboplastin Time values. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive 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 substantially equivalent data for Pacific Hemostasis and Dade Brand Coagulation Controls Level 3 (III) (Table 1). For both controls, a CV of less than 6% was obtained for PT and APTT between-run testing. The average CV's obtained for within-run precision were less than 4% for PT testing, and less than or equal to 2% for APTT testing of both products.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Between-run Precision (PH Data):
Prothrombin Time Testing: mean = 91.8, SD = 4.23, CV% = 4.61
Activated Partial Thromboplastin Time Testing: mean = 52.1, SD = 0.86, CV% = 1.65
Between-run Precision (Dade Data):
Prothrombin Time Testing: mean = 80.2, SD = 4.38, CV% = 5.46
Activated Partial Thromboplastin Time Testing: mean = 51.7, SD = 1.05, CV% = 2.02
Within-run Precision (PH Data):
Prothrombin Time Testing: 3.09% CV
Activated Partial Thromboplastin Time Testing: 1.55% CV
Within-run Precision (Dade Data):
Prothrombin Time Testing: 2.72% CV
Activated Partial Thromboplastin Time Testing: 1.35% CV
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K98413
510(K) Summary Coaqulation Control Level 3 (Abnormal)
PREMARKET NOTIFICATION 510(K) SUMMARY
Applicant:
1 1998
DEC ..
Laura A. Worfolk, Ph.D. Pacific Hemostasis 1515 Vanstory Drive Huntersville, NC 28078 (704) 948-3276
Contact Person:
Mark Ellis, Regulatory Affairs Manager, phone #(704) 948-3279 Fax # (704) 875-2092
| Date: | November 12, 1998 |
|---|---|
| Trade Name: | Coagulation Control Level 3 (Abnormal) |
| Common Name: | Abnormal Coagulation Control |
| Classification Name: | Plasma, Coagulation Control (per 21 CFR section 864.5425 |
| Equivalent Device: | Dade Ci-Trol Coagulation Control Level III, K771346 |
Description of Coagulation Control Level 3 (Abnormal)
Pacific Hemostasis Coagulation Control Level 3 (Abnormal) is a lyophilized preparation of citrated plasma obtained from healthy donors, which has been adjusted to yield prolonged Prothrombin Time and Activated Partial Thromboplastin Time values. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.
Intended Use of Coagulation Control Level 3 (Abnormal)
Pacific Hemostasis Coagulation Control Level 3 is intended for use as a control to monitor the performance of Prothrombin Time (PT) and Activated Partial Time (APTT) testing. It will yield PT and APTT values in the markedly abnormal range.
Summary of Performance Data for Substantial Equivalence Comparisons
Between-run and within-run precision studies yielded substantially equivalent data for Pacific Hemostasis and Dade Brand Coagulation Controls Level 3 (III) (Table 1). For both controls, a CV of less than 6% was obtained for PT and APTT between-run testing. The average CV's obtained for within-run precision were less than 4% for PT testing, and less than or equal to 2% for APTT testing of both products.
1
| | Prothrombin Time Testing | | Activated Partial
Thromboplastin Time Testing | |
|-----------------------------------------------------------------------------------------|----------------------------------------|----------------------------------------|--------------------------------------------------|----------------------------------------|
| | PH | Dade | PH | Dade |
| Between-run Precision
(20 duplicate
measurements over a 10
day period) | mean = 91.8
SD = 4.23
CV% = 4.61 | mean = 80.2
SD = 4.38
CV% = 5.46 | mean = 52.1
SD = 0.86
CV% = 1.65 | mean = 51.7
SD = 1.05
CV% = 2.02 |
| Within-run Precision
(3 runs of 20 duplicate
measurements, average
%CV shown.) | 3.09 | 2.72 | 1.55 | 1.35 |
Conclusion
Pacific Hemostasis and Dade brand Coagulation Control Level 3(III) have the same intended use, to monitor coagulation assays in the markedly abnormal range. Both are preparations of normal donor citrated plasma with added stabilizers and buffers, that have been adjusted to yield prolonged clotting times. The performance data presented here, as well as the indistinguishable intended use and technological characteristics support the substantial equivalence claim for Pacific Hemostasis Coagulation Control Level 3 to Dade Ci-Trol Coagulation Control Level III. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
2
PREMARKET NOTIFICATION
TRUTHFUL AND ACCURATE STATEMENT
[As required by 21 CFR 807.87(j)]
in
I certify that, in my capacity as a Research Scientist at Pacific Hemostasis, a Fisher Scientific Company, I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.
Laura A. Worfolk
Laura A. Worfolk, Ph.D.
11/12/98
K 984131
(Premarket Notification [510(k)] Number)
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three abstract human figures, represented by flowing lines, suggesting movement and connection.
DEC 11 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mark Ellis Requlatory Manager Pacific Hemostasis 11515 Vanstory Drive Huntersville, NC 28078
Re: K984131 Trade Name: Coagulation Control Level 3 (Abnormal) Requlatory Class: II Product Code: GGC Dated: November 16, 1998 November 18, 1998 Received:
Dear Mr. Ellis:
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 aqainst 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. this response to your premarket notification Please note: 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.
4
Page 2
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 leqally 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, "Misbrandinq 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 Butman
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
5
Statement of Indications for Use
Pacific Hemostasis Coagulation Control, Abnormal, Level 3, is intended for use as a control to Pacific Hemostasis Coagulation Annonia, Aonomia, Ecover, Resthrombin Time (PT) and monitor the performance or two Youthe "cought": "We markedly abnormal range.
Prescription ✓
Aster E. Madsen
Division of Clinical Laboratory Devices
510(k) Number K984131