(162 days)
Not Found
No
The document describes an in vitro diagnostic device for detecting lupus anticoagulants using a specific chemical method (dilute Russell's viper venom) and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) test used to detect lupus anticoagulants in plasma. It is not used to treat, cure, mitigate, or prevent disease, which are characteristics of a therapeutic device.
Yes
The "Intended Use / Indications for Use" states that the kits are "intended for the detection of lupus anticoagulants (LA) in plasma," which is a diagnostic purpose. The "Device Description" also refers to it as an "in vitro diagnostic device."
No
The device description explicitly states it is an "in vitro diagnostic device" and refers to "kits" and "reagents" used with "analyzers." This indicates a physical, hardware-based system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kits are "intended for the detection of lupus anticoagulants (LA) in plasma". This describes a test performed on a sample taken from the body (plasma) to provide information about a medical condition (lupus anticoagulants).
- Device Description: The "Device Description" section refers to the device as an "in vitro diagnostic device".
- Performance Studies: The performance studies involve testing "plasmas obtained from patients", which is characteristic of an in vitro diagnostic test.
These points clearly indicate that the device is designed to be used outside of the body to examine samples for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STA®-Staclot® dRVV Screen and STA®-Staclot® dRVV Confirm kits are intended for the detection of lupus anticoagulants (LA) in plasma by the dilute Russell's viper venom method (1) performed with analyzers of the STA® line suitable to these reagents.
Product codes (comma separated list FDA assigned to the subject device)
GIR
Device Description
The STA®-Staclot® dRVV Screen and STA®-Staclot® dRVV Confirm kits are intended for the detection of lupus anticoagulants (LA) in plasma by the dilute Russell's viper venom method (1) performed with analyzers of the STA® line suitable to these reagents.
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
Ninety plasmas obtained from patients with various clinical pathologies were tested with both kits at two sites. The percent agreement was 92%.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison study, Ninety plasmas, The percent agreement was 92%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 864.8950 Russell viper venom reagent.
(a)
Identification. Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.(b)
Classification. Class I (general controls).
0
K04.1805
1) 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: K061805
DEC - 6 2006
a) Applicant Name and Address
| Applicant: | Diagnostica Stago, Inc. |
|---|---|
| Address: | 5 Century Drive |
| Parsippany, NJ 07054 | |
| Contact Person: | Bob Wallish |
| Phone #: | 800-222-2624, x 2044 |
| Fax #: | 973-631-1618 |
| E-mail: | Bob.Wallish@stago-us.com |
| Date of Preparation: | 11/29/06 |
b) Device Name
| Trade Name: | STA® Staclot® dRVVT Screen and Confirm |
|---|---|
| Common Name: | Dilute Russell's Viper Venom Kits |
| Classification Name: | RUSSELL VIPER VENOM REAGENT (21 cfr 864.8950) Product Code GIR |
c) Predicate Device
LAC Screen and Confirm manufactured by Instrumentation Laboratories (K990302).
d) Intended Use/Device Description
The STA®-Staclot® dRVV Screen and STA®-Staclot® dRVV Confirm kits are intended for the detection of lupus anticoagulants (LA) in plasma by the dilute Russell's viper venom method (1) performed with analyzers of the STA® line suitable to these reagents.
e) Technological Characteristic Summary
The in vitro diagnostic device presented in this 510K submission, STA® -Staclote dRVV Screen and STA® -Staclot® dRVV Confirm, is substantially equivalent to the IL Test LAC Screen and Confirm manufactured by Instrumentation Laboratories. A comparison of the two kits is summarized in the following table.
Ninety plasmas obtained from patients with various clinical pathologies were tested with both kits at two sites. The percent agreement was 92%.
1
| Applicable Technology | STA® - Staclot® dRVV Screen and
Confirm | LAC Screen and LAC Confirm |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The STA®-Staclot® dRVV Screen
and STA®-Staclot® dRVV Confirm
kits are intended for the detection of
lupus anticoagulants (LA) in plasma
by the dilute Russell's viper venom
method performed with analyzers of
the STA® line suitable to these
reagents. | Diluted Russell's Viper Venom Test
(DRVVT) reagents for the detection of
lupus anticoagulants (a type of
phospholipid interfering antibody) in
human citrated plasma on the IL
Coagulation systems.
LAC Screen: Simplified DRVV
reagent to screen for the presence of
Lupus Anticoagulants
LAC Confirm: Phospholipid rich
DRVV reagent to confirm the
presence of Lupus Anticoagulants. |
| Reagent Composition | Russell's viper venom,
phospholipids, calcium and heparin
inhibitor. | Russell's viper venom, phospholipids,
calcium, heparin inhibitor, buffers,
stabilizers, dyes and preservative. |
| Reagent Stability | Intact vials at 2-8 °C: until expiration
Reconstituted on analyzer (15-20°C):
72 hours | Intact vials at 2-8 °C: until expiration
Reconstituted:
2-8 °C:48 hr
15-25 °C: 24 hr
-20 °C:1 mo |
| Test Sample | Citrated plasma | Citrated plasma |
| Expected Values | Normalized Ratio: Trade/Device Name: STA® STACLOT® dRVV Screen and Confirm Regulation Number: 21 CFR § 864.8950 Regulation Name: Russel viper venom reagent Regulatory Class: I Product Code: GIR Dated: October 25, 2006 Received: October 26, 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.
3
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,
lobatz Beckerh
Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: STA®-STACLOT® dRVV Screen and
STA®-STACLOT® dRVV Confirm
Indications for Use:
The STA®-Staclot® dRVV Screen and STA®-Staclot® dRVV Confirm kits are intended for the detection of lupus anticoagulants (LA) in plasma by the dilute Russell's viper venom method (1) performed with analyzers of the STA® line suitable to these reagents.
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
KO61804 510(k)________________________________________________________________________________________________________________________________________________________________________
Prescription Use (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)
Page of of