(49 days)
No
The summary describes a standard in vitro diagnostic clotting assay and does not mention any AI or ML components.
No
Explanation: This device is an in vitro diagnostic device used to determine Protein S activity in human plasma, which helps diagnose conditions. It does not directly treat or cure any medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The ACTICLOT® Protein S clotting assay is an in vitro diagnostic device..." and explains it's for quantitative determination of Protein S activity in human plasma, which is used to diagnose conditions like Protein S deficiencies and assess risk of thromboembolism.
No
The device is an in vitro diagnostic clotting assay, which is a laboratory test that involves reagents and physical processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in both the "Intended Use / Indications for Use" and "Device Description" sections that the ACTICLOT® Protein S clotting assay is an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ACTICLOT Protein S is an in vitro diagnostic clotting assay for the quantitative determination of Protein S activity in human plasma.
The ACTICLOT® Protein S clotting assay is an in vitro diagnostic device intended for the quantitative determination of Protein S activity in human plasma.
Protein S activity levels in plasma are known to be low in patients with congenital Protein S deficiencies type-I, type-IIb, and type-IIb, and may also be low in pregnant I fotom & donemelers with liver disease and in inflammatory disease in which levels of C4b wonline in patients with are elevated. A decrease in Protein S activity is associated with an increased incidence of thromboembolism.
Product codes
GGP
Device Description
ACTICLOT Protein S Product # 843L
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
Method comparison studies versus the predicate device were performed with two different lots of ACTICLOT Protein S. The regression statistics in Table 1 indicate a positive correlation between the ACTICLOT assay and the predicate device.
Lot 1: n = 78, Regression Equation Y = 0.91X + 17.2, R = 0.868, Sy.x = 12.3 % Activity, Sample Range 22-114 % Activity.
Lot 2: n = 37, Regression Equation Y = 1.06X - 7.5, R = 0.916, Sy.x = 14.2 % Activity, Sample Range 18-117 % Activity.
Precision studies evaluated intra-assay and inter-assay variability with 2 control samples run in replicates of 4 over 20 runs (n = 80 per control).
Precision Table:
Normal Control Level: Mean = 86.8 % Activity, Intra-Assay CV% = 3.0, Inter-Assay CV% = 5.9.
Abnormal Control Level: Mean = 41.9 % Activity, Intra-Assay CV% = 2.3, Inter-Assay CV% = 5.1.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).
0
Section 3
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
ACTICLOT® Protein S Quantitative Factor Deficiency Test (per 21CFR864.7290)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K010386
Submitted by:
American Diagnostica Inc. 222 Railroad Avenue Greenwich, CT 06830 Phone: 203 661-0000 Fax: 203 661-7784
Contact:
Clare Santulli Field Trial Coordinator Phone: 203 661-0000
Summary Prepared:
July 8, 2001
Name of the Device:
ACTICLOT Protein S Product # 843L
Classification Name(s):
Factor Deficiency Test, Class II 864.7290 81GGP Test, Qualitative and Quantitative Factor Deficient
Predicate Device:
BIOCLOT Protein S-300 ACT K955738
Intended Use:
ACTICLOT Protein S is an in vitro diagnostic clotting assay for the quantitative determination of Protein S activity in human plasma.
1
Summary of Substantial Equivalence:
ACTICLOT Protein S is substantially equivalent to the commercially available predicate device (BIOCLOT Protein S-300 ACT, manufactured by Biopool International, Ventura, CA) in performance and intended use.
Summary of Performance Data:
Method Comparison
Method comparison studies versus the predicate device were performed with two different lots of ACTICLOT Protein S. The regression statistics in Table 1 indicate a positive correlation between the ACTICLOT assay and the predicate device.
| Table 1: Correlation (Y = ACTICLOT, X = predicate device) | LE MARK STATUS STATE AND STATE A BEACH AND A BEACH AND A BREAK A BALL A BEA A BALL A BEA BE A BARRET A BARRET A BARRET A BARRET A BARRET A BARRET A BARRET A BARRET A BARRET A | ||||
|---|---|---|---|---|---|
| ----------------------------------------------------------- | -- | -- | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
| ACTICLOT
Lot | n | Regression Equation | R | Sy.x
(% Activity) | Sample Range
(% Activity) |
|-----------------|----|---------------------|-------|----------------------|------------------------------|
| 1 | 78 | Y = 0.91X + 17.2 | 0.868 | 12.3 | 22-114 |
| 2 | 37 | Y = 1.06X - 7.5 | 0.916 | 14.2 | 18-117 |
Precision
Precision studies evaluated intra-assay and inter-assay variability with 2 control samples run in replicates of 4 over 20 runs (n = 80 per control).
Table 2: Precision
| Control
Level | Mean
(% Activity) | Intra-Assay
CV% | Inter-Assay
CV% |
|------------------|----------------------|--------------------|--------------------|
| Normal | 86.8 | 3.0 | 5.9 |
| Abnormal | 41.9 | 2.3 | 5.1 |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 4 2001
Mr. John B. Berryman Director of Regulatory Affairs American Diagnostica Inc. 222 Railroad Avenue Greenwich, CT 06830
Re: K012386
Trade/Device Name: ACTICLOT® Protein S Regulation Number: 21 CFR 864.7290 Regulation Name: Factor deficiency test Regulatory Class: Class II Product Code: GGP Dated: July 20, 2001 Received: July 27, 2001
Dear Mr. Berryman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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
4
510(k) Notification
Section 2
STATEMENT OF INDICATIONS FOR USE
Applicant: __ American Diagnostica Inc. __
510(k) Number: _ Ko12386
Device:
Indications for Use:
The ACTICLOT® Protein S clotting assay is an in vitro diagnostic device intended for the quantitative determination of Protein S activity in human plasma.
Protein S activity levels in plasma are known to be low in patients with congenital Protein S deficiencies type-I, type-IIb, and type-IIb, and may also be low in pregnant I fotom & donemelers with liver disease and in inflammatory disease in which levels of C4b wonline in patients with are elevated. A decrease in Protein S activity is associated with an increased incidence of thromboembolism.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Owision/Sign-Off) Division of Clinical Laboratory Devices
510(k) Number K012386