(31 days)
Not Found
No
The summary describes a quality control kit for laboratory tests and does not mention any AI or ML components.
No.
The device is described as a quality control kit for laboratory tests, not for direct treatment or diagnosis of a disease.
No
The device is described as a "quality control" kit, providing LA negative and positive plasmas for verifying the performance of LA detection tests, rather than directly diagnosing a patient condition.
No
The device description explicitly states that the device is a "kit" providing "plasma," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the plasmas are for "quality control of the tendsma for LA detection carried out with the following tests". These tests (STA® -Staclor® dRVV Screen, STA® -Staclot® dRVV Confirm, Staclot® LA) are themselves IVD tests used to detect lupus anticoagulants in patient samples.
- Device Description: The description confirms that the kit provides plasmas for "quality control of LA testing using the following kits". This reinforces its role in supporting the performance of other IVD tests.
- Predicate Device: The mention of a predicate device (K952623 Cryocheck Lupus Positive Control) which is also a control for lupus anticoagulant testing, further indicates that this type of product is classified as an IVD.
Control materials used to verify the performance of diagnostic tests are considered IVDs themselves, as they are essential components in ensuring the accuracy and reliability of the diagnostic process.
N/A
Intended Use / Indications for Use
The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of LA testing using the following kits: STA® - Staclot® dRVV Screen (#00339 & 00333) STA® - Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594).
Product codes
GGC, GGN
Device Description
The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of LA testing using the following kits: STA® - Staclot® dRVV Screen (#00339 & 00333) STA® - Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594).
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)
Not Found
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 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
JUL 2 8 2006
Diagnostica Stago Inc. STA® - Control LA 1+2 510K Summary
11) 510K Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: -----------------------------------------------------------------------------------------------------------------------------------------------
a) Applicant Name and Address
| Applicant: | Diagnostica Stago, Inc. |
|---|---|
| Address: | 5 Century Drive |
| Parsippany, NJ 07054 | |
| Contact Person: | Melissa Cole |
| Phone #: | 800-222-2624, x 4416 |
| Fax #: | 973-631-1618 |
| E-mail: | Melissa.Cole@stago-us.com |
| Date of Preparation: | June 22, 2006 |
b) Device Name
| Trade Name: | STA® - Control LA 1+2 |
|---|---|
| Common Name: | Lupus Control Plasmas |
| Classification Name: | Plasma, Control, Normal & Abnormal |
c) Predicate Device
Cryocheck Lupus Positive Control (K952623) manufactured by Precision Biologic, Inc. Dartmouth, Nova Scotia, Canada.
d) Intended Use/Device Description
The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of LA testing using the following kits:
STA® - Staclot® dRVV Screen (#00339 & 00333) STA® - Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)
e) Technological Characteristic Summary
STA® - Control LA 1+2 and Cryocheck Lupus Positive Control are human citrated plasmas intended for control of Lupus Anticoagulant testing (i.e. DRVVT and Staclot LA).
1
DEPARTMENT OF HEALTH & HI MAN SERVICES
Public Feath Service
Food and Drug Aomin stration 2098 Garther Road Воскивае МО 20850
Laura A. Worfolk, Ph.D. Acting Director. Quality Control and Regulatory Affairs Diagnostica Stago, Inc. Five Century Drive Parsippany. New Jersey 07054
JUL 28 2006
Re: K061803 Trade/Device Name: STA®- Control LA 1+2 Regulation Number: 21 CFR § 864.5425 Regulation Name: Plasma, Control, Normal & Abnormal Regulatory Class: II Product Code: GGC, GGN Dated: June 23, 2006 Received: June 27, 2006
Dear Dr. Worfolk:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
2
Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html
Sincerely yours,
Robert L. Becker Jr.
Robert L. Becker, Jr., MD, PK. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: STA 8 - Control LA 1+2
Indications for Use:
The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of the tendsma for LA detection carried out with the following tests:
STA® -Staclor® dRVV Screen (#00339 & #00333) STA® -Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Page
See Device
510(k) K061803