(72 days)
Not Found
No
The description focuses on photo-optical principles and standard laboratory testing methods without mentioning AI or ML.
No
The device is an in-vitro diagnostic instrument used for coagulation testing in the clinical laboratory, not for direct therapeutic intervention on patients.
Yes
The device is used for "in-vitro diagnostic coagulation testing" and performs "in-vitro diagnostic clotting and chromogenic procedures." Diagnostic tests are inherently used for diagnosis.
No
The device description explicitly states it is a "photo-optical instrument" with hardware components like a halogen lamp and incubator block, indicating it is a physical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states: "The Pacific Hemostasis ThromboScreen® 400C is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma samples in the clinical laboratory." This directly identifies its purpose as an in-vitro diagnostic device.
- Device Description: The description reiterates that it is used for "performance of in-vitro diagnostic clotting and chromogenic procedures in the clinical laboratory."
- Function: The device performs tests on biological samples (citrated plasma) outside of the body ("in-vitro") to provide information about a patient's health status (coagulation testing). This is the core definition of an IVD.
- Setting: It is intended for use in a "clinical laboratory," which is a typical setting for IVD testing.
The information provided clearly indicates that the ThromboScreen® 400C is designed and intended for use as an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pacific Hemostasis ThromboScreen® 400C is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma samples in the clinical laboratory. The ThromboScreen® 400C has both clot and chromogenic testing capabilities. Assays performed on the instrument include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (Clauss and Derived methods), and PT and APTT-based factor assays. Chromogenic tests include assays such as Antithrombin III, Protein C and Heparin Xa.
Product codes
KQG
Device Description
The ThromboScreen® 400C (TS400C) is a photo-optical instrument used for the performance of in-vitro diagnostic clotting and chromogenic procedures in the clinical laboratory. The instrument utilizes photo-optical principles for both clotting and chromogenic assays. The ThromboScreen® 400C light source is provided by a halogen lamp. The incubator block is temperature regulated to 36.5 - 37.5℃ and contains four measuring positions, five reagent and 24 cuvette prewarming positions. A detailed description of the device, including an explanation of how it functions, is described in the ThromboScreen® 400C Operator's Manual, section 1, Introduction.
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
Clinical laboratory
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
Within-run and between-run precision studies, and method comparison studies were performed.
Within-run precision studies were summarized in Table 1 with data for PT, APTT, Clauss Fib., Derived Fib., Factor V, Factor VIII, and Chromogenic ATIII.
Between-run precision testing was summarized in Table 2 for PT, APTT, Clauss Fib., and ATIII.
Method comparison studies between the TS400C and the MLA-900C/1000C were summarized in Table 3.
Sample sizes for method comparison studies included:
- Prothrombin Time (PT): Site #1 - 94, Site #2 - 139
- Derived Fibrinogen: Site #1 - 47
- Activated Partial Thromboplastin Time (APTT): Site #1 - 93, Site #2 - 117
- Clauss Fibrinogen: Site #1 - 50, Site #2 - 20
- Factor VIII: Site #1 - 49
- Factor V: Site #1 - 50
- Chromogenic ATIII: Site #1 - 58
Key results: Correlation Coefficients (r) were generally high (0.96 to 0.99) for most tests, with Chromogenic ATIII having an r of 0.88. Regression equations were also provided for each comparison.
Key Metrics
Correlation Coefficient, Regression Equation, %CV
Predicate Device(s)
MLA-900C, #K884863, MLA-1000C, #K894052
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
PREMARKET NOTIFICATION 510(K) SUMMARY 10.0
| Applicant: | Laura A. Worfolk, Ph.D.
Pacific Hemostasis
11515 Vanstory Drive
Huntersville, NC 28078
704-875-0494
Fax # 704-875-2092 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Laura A. Worfolk
Phone: 704-875-0494
Fax #: 704-875-2092 |
| Date: | June 21, 1999 |
| Trade Name: | Pacific Hemostasis ThromboScreen® 400C |
| Common Name: | Manual Coagulation Instrument |
| Classification Name: | Instrument, Coagulation (per 21 CFR section 864.5400) |
| Equivalent Devices: | MLA-900C, #K884863 & the MLA-1000C, #K894052 |
Description of the ThromboScreen® 400C
The ThromboScreen® 400C (TS400C) is a photo-optical instrument used for the performance of in-vitro diagnostic clotting and chromogenic procedures in the clinical laboratory. The instrument utilizes photo-optical principles for both clotting and chromogenic assays. The ThromboScreen® 400C light source is provided by a halogen lamp. The incubator block is temperature regulated to 36.5 - 37.5℃ and contains four measuring positions, five reagent and 24 cuvette prewarming positions. A detailed description of the device, including an explanation of how it functions, is described in the ThromboScreen® 400C Operator's Manual, section 1, Introduction.
Intended Use of the ThromboScreen® 400C
The Pacific Hemostasis ThromboScreen® 400C is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma samples in the clinical Coagulation testing capabilities of the device include routine clotting tests such as laboratory. Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (Clauss and Derived methods), as well as PT and APTT-based factor assays. Chromogenic tests include assays such as Antithrombin III, Protein C and Heparin Xa.
1
Summary of Substantial Equivalence Comparisons
The ThromboScreen® 400C (TS400C) was compared to the MLA-900C and the MLA-1000C (K884863 & K894052, respectively). All three instruments have a similar intended use: for in-vitro diagnostic coagulation testing in the clinical laboratory. Further, the proposed device and the predicate devices utilize photo-optical measurement principles for both clot and chromogenic based assays,
The TS400C is a "manual" coagulation instrument, in that the user must pipet both sample and test reagent. In contrast, the MLA-900C is semi-automated, and the MLA-1000C is a fully-automated instrument. The MLA-900C requires manual sample addition, but has an automatic pipet for reagent addition. The MLA-1000C has an automatic pipetting system, which adds both sample and test reagent. The light source for the MLA instruments is a halogen lamp and the wavelength is set at 550 nm for clotting assays, and 405 nm for chromogenic assays. A halogen lamp is also utilized by the TS400C, however a 405 nm filter is used for both clotting and chromogenic assays. Although the TS400C utilizes a different wavelength for clotting assays compared to the MLA, it has been optimized for this specific light source/filter combination. The performance data generated support this statement (Tables 1-3).
Within-run and between-run precision studies were performed using Pacific Hemostasis (PH) brand reagents. Tables 1 and 2 summarize the data obtained from these studies. Comparison testing performed is shown in Table 3. Specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions, which are expected to affect the results for a particular assav. For derived Fibrinogen comparison testing, extrapolated data was included in the Note: analysis. This was done so that a wide range of Fibrinogen results could be compared between the two instruments. In a normal clinical testing situation, patient values above the highest standard curve point are not reported. Rather, the user is advised to report the result as greater than the highest standard curve value, and use the Clauss methodology for Fibrinogen testing (page 48 of the Operator's Manual).]
2
| Test | TS400C | MLA | |||||
|---|---|---|---|---|---|---|---|
| Low | Normal | High | Low | Normal | High | ||
| PT | Site 1 | 1.9 | 2.5 | 1.1 | 3.8 | ||
| Site 2 | 4.3 | 5.2 | 1.5 | 2.0 | |||
| APTT | Site 1 | 5.4 | 3.1 | 0.8 | 0.9 | ||
| Site 2 | 2.4 | 4.1 | 3.3 | 2.2 | |||
| Clauss Fib. * | 7.2 | 6.7 | 6.4 | 2.8 | 1.2 | 3.8 | |
| Derived Fib. * | 7.5 | 2.6 | 2.3 | 4.4 | 3.4 | 2.1 | |
| Factor V* | 4.0 | 4.5 | 1.2 | 2.0 | |||
| Factor VIII* | 9.9 | 9.7 | 5.3 | 4.7 | |||
| Chromogenic | |||||||
| ATIII* | 6.9 | 4.9 | 10.1 | 3.2 |
Table 1. Summary of Within-run Precision Studies, %CV
*Testing at Site 1 only. (Shaded areas, no testing performed. Only clinically significant ranges tested.) Note: MLA-1000C used at Site 1, MLA-900C used at Site 2.
| TS400C | MLA-1000C | ||||||
|---|---|---|---|---|---|---|---|
| Test | Low | Normal | High | Low | Normal | High | |
| PT | 3.4 | 6.0 | 1.4 | 4.5 | |||
| APTT | 2.5 | 1.8 | 1.4 | 1.2 | |||
| Clauss Fib. | 4.1 | 4.0 | 2.9 | 5.5 | 4.5 | 4.9 | |
| ATIII | 9.4 | 4.5 | 9.9 | 5.1 |
Table 2. Summary of Between-run Precision Testing*
*Testing performed at Site 1 only.
3
| Test | Site & Sample # | Correlation
Coefficient, r | Regression Equation |
|------------------------------------------|-----------------|-------------------------------|----------------------|
| (Reagent, Unit) | | | |
| Prothrombin Time (PT) | Site #1 - 94 | 0.99 | y = 1.045x - 0.3358 |
| (Thromboplastin DS,
seconds) | Site #2 - 139 | 0.99 | y = 1.141x - 1.5248 |
| Prothrombin Time | Site #1 - 94 | 0.98 | y = 0.9395x + 0.1153 |
| (Thromboplastin DS, INR) | Site #2 - 139 | 0.99 | y = 0.9955x + 0.0617 |
| Derived Fibrinogen | Site #1 - 47 | 0.98 | y = 1.0093x + 0.1442 |
| (Thromboplastin DS,
mg/dL) | | | |
| Activated Partial
Thromboplastin Time | Site #1 - 93 | 0.98 | y = 1.1449x + 1.3424 |
| (APTT-LS reagent,
seconds) | Site #2 - 117 | 0.96 | y = 0.9955x + 0.0617 |
| Clauss Fibrinogen | Site #1 - 50 | 0.98 | y = 0.9366x + 27.28 |
| (Thrombin reagent,
mg/dL) | Site #2 - 20 | 0.98 | y = 0.9843x + 3.2104 |
| Factor VIII | Site #1 - 49 | 0.97 | y = 1.04x - 0.8112 |
| (APTT-LS, % activity) | | | |
| Factor V, | Site #1 - 50 | 0.97 | y = 1.0511 - 5.6923 |
| (Thromboplastin DS, %
activity) | | | |
| Chromogenic ATIII | Site #1 - 58 | 0.88 | y = 0.9417x + 7.6005 |
| (ATIII Chromogenic Kit,
%) | | | |
| Table 3. Summary of Method Comparison Studies Between the TS400C & the MLA-900C/1000C | |||||
|---|---|---|---|---|---|
| -- | -- | -- | --------------------------------------------------------------------------------------- | -- | -- |
Note: Site 1 used the MLA-1000C, Site 2 the MLA-900C.
In conclusion, the similar intended use, technological characteristics and the combined performance data support the claim that the ThromboScreen® 400C is substantially equivalent to the MLA-900C and the MLA-1000C.
4
11.0 ATTACHMENTS
- ThromboScreen® 400C Operator's Manual. 1.
- The Introduction section of the MLA-1000C Operator's Manual. (With the exception of the 2. Automatic Primary Tube Sampler, the MLA-900C is the same system as the MLA-1000C. Therefore Refer to page 1-1 of the MLA-1000C the MLA-900C Operator's Manual was not included. Operator's Manual.)
-
- TS400C Power Supply approval certificates.
-
- Manufacturer's Certificate of Software Traceability.
- Manufacturer's Certificate of Y2K Compatibility. 5.
5
Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping shapes that resemble birds in flight. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
3 1999 SEP
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Laura A. Worfolk, Ph.D. Principal Research Scientist Pacific Hemostasis 11515 Vanstory Drive, Suite 125 11315 Vanstory Dr. Program 28078-8144 ·
K992130 K992130
Trade Name: Pacific Hemostasis ThromboScreen® 400C (TS400C) Re: Regulatory Class: II Product Code: KQG Dated: June 22, 1999 Received: June 23, 1999
Dear Dr. Worfolk:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 510(c) notification of the minent (for the indications for use
above and we have determined the devices marked in interstate commerce above and we have determined the devices marketed products (top interstate commerce
stated in the enclosure) to legally marketed previce Americal in interstate commence stated in the enclosure) to legally marketed predical Device Amendments, or to devices that
prior to May 28, 1976, the enactment date of the Federal Food, Drug, and prior to May 28, 1976, the enatment and on the Federal Food, Drug, and have been reclassified in accordance with the provisions of the Peneral controls
Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmetic Act (Act). You may, therefore, market the Act include requirements for annual
provisions of the Act. The general controls provisions of the Act include requirement provisions of the Act. The general controls provisions of the Host. For I
registration, listing of devices, good manufacturing practice, labeling, and prohibitions against
a misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III
n treass If your device is classified (see above) into elder class in (opertials major regulations)
(Premarket Approval), it may be subject to such additions. Title 21, Parts 800 to 8 (Premarket Approval), it may be subject to such auch as mile 21, marts 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 affecting your device can be found in the counds compliance with the Current Good
A substantially equivalent determination assumes compliance with the Current Regulation (C A substantially equivalent determination assumes compilation (QS) for
Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) Manufacturing Practice requirements, as ser form in the Quad that, through periodic QS
Medical Devices: General regulation (21 CFR Part 820) and that, through periodic of Medical Devices: General regulation (ZI CFK Fart 620) will verify such assumptions. Failure to
inspections, the Food and Drug Administration (FDA) will verify such assumpti inspections, the Food and Drug Administration (r bring basilion, FDA may publish
comply with the GMP regulation may result in regulatory action. Please note: this comply with the GMP regulation in the Federal Register. Please note: this further announcements concerning your device in the reasing and affect any obligation you might
response to your premarket notification submission does not affectronic Produc response to your premarket notification submission actives under the Electronic Product
have under sections 531 through 542 - The Act lows or reaulations have under sections 551 through of ID CFE Federal laws or regulations.
6
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may Onder the Chillour Baberatory Inspiration. 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 I his letter will and w Jour of substantial equivalence of your device to a legally marketed notification. The PDF Intellig of Gestion 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 additionally, 0071100111, 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
7
Page__of_
| i10(k) Number (if known): | K992130 |
|---|---|
| --------------------------- | --------- |
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
STATEMENT OF INDICATIONS FOR USE
The Pacific Hemostasis ThromboScreen® 400C is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma samples in the clinical laboratory. The ThromboScreen® 400C has both clot and chromogenic testing capabilities. Assays performed on the instrument include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (Clauss and Derived methods), and PT and APTT-based factor assays. Chromogenic tests include assays such as Antithrombin III, Protein C and Heparin Xa.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Clinical Laboratory Devices | |
| 510(k) Number | K992130 |
Prescription Use
OR
Over-The-Counter Use
Prescri (Per 21 CFR 801.109)
OR
ver-The-Counter osc.
(Optional Format 1-2-96)