(120 days)
Not Found
No
The description focuses on a chromogenic assay technique and standard laboratory procedures for calibration and quality control. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic (IVD) test kit used for the quantitative determination and quality control of heparin levels in plasma, which is a diagnostic function, not a therapeutic one.
Yes
The device quantitatively determines the plasma levels of heparins by measuring anti-Xa activity, which is used to assess a patient's heparin levels for medical management. This measurement provides diagnostic information about the patient's coagulation status related to heparin treatment.
No
The device description clearly outlines the use of physical reagents (chromogenic assay kits, lyophilized human plasmas) and relies on specific hardware analyzers (STA-R®, STA Compact®, and STA Satellite®) to perform the intended function. This is an in vitro diagnostic assay with hardware and reagent components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the kits are for the "quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity". This is a diagnostic measurement performed on a biological sample (plasma) to provide information about a patient's health status (heparin levels).
- Device Description: The description details a "chromogenic assay technique" that uses reagents to analyze a biological sample (plasma). This is a typical description of an in vitro diagnostic test.
- Sample Type: The input is plasma, which is a biological sample taken from a patient.
- Performance Studies: The document describes performance studies like precision, detection limit, linearity, and interference, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Devices: The mention of predicate devices with K numbers indicates that this device is being compared to previously cleared IVD devices.
All of these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease.
N/A
Intended Use / Indications for Use
- STA® Liquid Anti-Xa: The STA® Liquid Anti-Xa kits are intended for use with STA-R®, V STA Compact® and STA Satellite® analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
- STA® Multi Hep Calibrator: The STA® Multi Hep Calibrator is a set of calibrator plasmas intended for use with STA-R®, STA Compact®, and STA Satellite® analyzers, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity.
- STA® Quality HNF/UFH: The STA® Quality HNF/UFH kit is a set of two plasmas > intended for the quality control of unfractionated heparin (UFH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact®, and STA Satellite® analyzers.
- STA® Quality HBPM/LMWH: The STA® Quality HBPM/LMWH kit is a set of two > plasmas intended for the quality control of low molecular weight heparin (LMWH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact®, and STA Satellite®.
Product codes (comma separated list FDA assigned to the subject device)
KFF, JIT, GGN
Device Description
- STA® - Liquid Anti-Xa: The STA® - Liguid Anti-Xa is a chromogenic assay technique used for determination of the level of UFH and LMWH that have high affinity for antithrombin by measuring their anti-Xa activity. The normal function of a molecule of factor Xa, when present in plasma, is to cleave its natural substrate, prothrombin, to generate thrombin, the enzyme responsible for the formation of the fibrin clot. In the presence of heparin, competition occurs between this mechanism and the inhibitory mechanism exerted by the heparin-antithrombin complex, this inhibition being largely responsible for the anticoagulant action of heparin. The proposed method is a one-step reaction based on a similar principle: as soon as factor Xa is added to the plasma-substrate mixture, two reactions take place simultaneously, namely, hydrolysis of the substrate by factor Xa and inhibition of factor Xa by the heparin-antithrombin complex*. After the necessary period of time for the competitive reaction to reach equilibrium, the quantity of paranitroaniline that is released is inversely proportional to the concentration of heparin present in the test medium. * The heparin-antithrombin complex is made up from the heparin and the antithrombin (AT) peculiar to the patient.
- STA® - Multi Hep Calibrator: The STA® - Multi Hep Calibrator reagents are lyophilized human plasmas at five different heparin concentrations. They are used to create the calibration curve on STA-R®, STA Compact®, and STA Satellite® analyzers performing the chromogenic method for heparin (UFH and LMWH) using STA® - Liquid Anti-Xa. Three kinds of calibration are possible, depending on the type of molecule to be determined: a calibration with the Reagents 1, 2, 3, 4 and 5 for UFH and/or LMWH assays, a calibration with the Reagents 1, 2 and 4 dedicated to UFH assays, a calibration with the Reagents 1, 3 and 5 dedicated to LMWH assays.
- STA® - Quality HNF/UFH: The STA® - Quality HNF/UFH reagents are lyophilized human plasmas at two different UFH concentrations. They are used for the quality control of UFH activity assay by measuring the anti-Xa activity using the chromogenic method STA® - Liquid Anti-Xa performed on STA-R®, STA Compact®, and STA Satellite® analyzers.
- STA® - Quality HBPM/LMWH: The STA® - Quality HBPM/LMWH reagents are lyophilized human plasmas at two different LMWH concentrations. They are used for the quality control of LMWH activity assay by measuring the anti-Xa activity using the chromogenic methods, STA® - Liquid Anti-Xa and STA® - Rotachrom® Heparin, performed on STA-R®, STA Compact, and STA Satellite® analyzers.
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
Prescription Use
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)
- Precision studies were performed according to the CLSI guideline EP5-A2 using samples containing heparin (22 days, 2 runs per day).
- Hybrid calibration (5-point calibration):
- Sample 1 (UFH) Mean: 0.21 IU/mL, Repeatability SD: 0.013 IU/mL, CV: 6.2%, Within-laboratory precision SD: 0.021 IU/mL, CV: 9.9%
- Sample 2 (UFH) Mean: 0.55 IU/mL, Repeatability SD: 0.017 IU/mL, CV: 3.1%, Within-laboratory precision SD: 0.036 IU/mL, CV: 6.6%
- Sample 3 (UFH) Mean: 0.97 IU/mL, Repeatability SD: 0.033 IU/mL, CV: 3.4%, Within-laboratory precision SD: 0.053 IU/mL, CV: 5.5%
- Sample 4 (LMWH) Mean: 0.86 IU/mL, Repeatability SD: 0.027 IU/mL, CV: 3.1%, Within-laboratory precision SD: 0.041 IU/mL, CV: 4.8%
- Sample 5 (LMWH) Mean: 1.48 IU/mL, Repeatability SD: 0.045 IU/mL, CV: 3.0%, Within-laboratory precision SD: 0.075 IU/mL, CV: 5.1%
- Sample 6 (LMWH) Mean: 1.75 IU/mL, Repeatability SD: 0.050 IU/mL, CV: 2.9%, Within-laboratory precision SD: 0.087 IU/mL, CV: 5.0%
- Dedicated calibration (3-point calibration):
- Sample 1 (UFH) Mean: 0.22 IU/mL, Repeatability SD: 0.012 IU/mL, CV: 5.6%, Within-laboratory precision SD: 0.020 IU/mL, CV: 9.2%
- Sample 2 (UFH) Mean: 0.55 IU/mL, Repeatability SD: 0.017 IU/mL, CV: 3.0%, Within-laboratory precision SD: 0.033 IU/mL, CV: 6.1%
- Sample 3 (UFH) Mean: 0.97 IU/mL, Repeatability SD: 0.034 IU/mL, CV: 3.5%, Within-laboratory precision SD: 0.050 IU/mL, CV: 5.1%
- Sample 4 (LMWH) Mean: 0.86 IU/mL, Repeatability SD: 0.028 IU/mL, CV: 3.2%, Within-laboratory precision SD: 0.045 IU/mL, CV: 5.2%
- Sample 5 (LMWH) Mean: 1.48 IU/mL, Repeatability SD: 0.045 IU/mL, CV: 3.1%, Within-laboratory precision SD: 0.078 IU/mL, CV: 5.3%
- Sample 6 (LMWH) Mean: 1.75 IU/ML, Repeatability SD: 0.050 IU/mL, CV: 2.8%, Within-laboratory precision SD: 0.089 IU/mL, CV: 5.1%
- Hybrid calibration (5-point calibration):
- Detection Limit - Working Range: The limit of detection and linearity were assessed for each method according to the CLSI quidelines EP17-A and EP6-A respectively. In the UFH/LMWH method with the STA® - Multi Hep Calibrator (5-point calibration) the detection threshold on the STA-R® is 0.10 IU/ml (UFH and LMWH) and the linearity range extends to 1.10 IU/ml for the UFH and to 2.00 anti-Xa IU/ml for the LMWH. In the UFH method with the STA® - Multi Hep Calibrator (UFH 3-point calibration), the detection threshold on the STA-R® is 0.10 IU/ml and the linearity range extends to 1.10 IU/ml. In the LMWH method with the STA® - Multi Hep Calibrator (LMWH,3-point calibration) the detection threshold on the STA-R® is 0.10 anti-Xa IU/ml and the linearity range extends to 2.00 anti-Xa IU/ml.
- Interfering substances: The STA® - Liquid Anti-Xa method (UFH and LMWH protocols) is insensitive to the following substances: hemoglobin (up to 1.5 g/l), conjugated bilirubin (up to 288 mg/l -342 µmol/), unconjugated bilirubin (up to 138 mg/l - 236 µmol/l) and triglycerides (up to 6.9 g/l - 8 mmol/l). The tests were performed according to the CLSI guideline EP7-A2.
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.
K010455, K010350, K854762, K943520, K010324
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
§ 864.7525 Heparin assay.
(a)
Identification. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the word "Stago" in a stylized font, with a symbol above it that resembles three curved shapes forming a circular pattern. Below the word "Stago", there is the text "510(k) Summary" in a smaller, bold font. The text indicates that the image is likely related to a summary document for a medical device or product requiring 510(k) clearance.
1822
OCT 2,6 2011
Submitter's Information
Diagnostica Stago, Inc. Five Century Drive Parsippany, New Jersey 07054
Phone: (973) 631-1200, x-4117 Facsimile: (973) 867-6859
Date Prepared: October 25, 2011
Application Correspondent and Contact Person:
Carlo d'Alessandro, Director, IVD Quality and Regulatory DONAWA LIFESCIENCE CONSULTING Piazza Albania, 10 - 00153 Rome, Italy Phone: +39 06 578 2665 Facsimile:+39 06 574 3786
Device Names :
| Trade names
(products sold separately) | Common names | Classification name | Product
Code |
|-------------------------------------------|--------------------|------------------------------------------------|-----------------|
| STA® - Liquid Anti-Xa | Heparin Assay | Heparin Assay
21 CFR 864.7525 | KFF |
| STA® - Multi Hep Calibrator | Heparin Calibrator | Calibrator, secondary
21 CFR 862.1150 | JIT |
| STA® - Quality HNF/UFH | Heparin Control | Plasma, coagulation control
21 CFR 864.5425 | GGN |
| STA® - Quality HBPM/LMWH | Heparin Control | Plasma, coagulation control
21 CFR 864.5425 | GGN |
Predicate Devices
| Predicate Device name | 510(k) number |
|---|---|
| STA® - Rotachrom® Heparin | K010455 |
| STA® - Calibrator HBPM/LMWH | K010350 |
| STA® - Hepanorm® H | |
| {formerly cleared as Hepanorm® | |
| Calibration Plasma Set} | K854762 |
| STA® - Heparin Control | K943520 |
| STA® - Quality HBPM/LMWH | K010324 |
1
Image /page/1/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with a stylized graphic above it. The graphic appears to be composed of three curved shapes arranged in a circular pattern, creating a sense of movement or rotation.
Device Intended Use
- STA® Liquid Anti-Xa: The STA® Liquid Anti-Xa kits are intended for use with STA-R®, V STA Compact® and STA Satellite® analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
- ✔ STA® Multi Hep Calibrator: The STA® Multi Hep Calibrator is a set of calibrator plasmas intended for use with STA-R®, STA Compact®, and STA Satellite® analyzers, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity.
- STA® Quality HNF/UFH: The STA® Quality HNF/UFH kit is a set of two plasmas > intended for the quality control of unfractionated heparin (UFH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact®, and STA Satellite® analyzers.
- STA® Quality HBPM/LMWH: The STA® Quality HBPM/LMWH kit is a set of two > plasmas intended for the quality control of low molecular weight heparin (LMWH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact®, and STA Satellite®.
Device descriptions
✓ STA® - Liquid Anti-Xa:
The STA® - Liguid Anti-Xa is a chromogenic assay technique used for determination of the level of UFH and LMWH that have high affinity for antithrombin by measuring their anti-Xa activity.
The normal function of a molecule of factor Xa, when present in plasma, is to cleave its natural substrate, prothrombin, to generate thrombin, the enzyme responsible for the formation of the fibrin clot. In the presence of heparin, competition occurs between this mechanism and the inhibitory mechanism exerted by the heparin-antithrombin complex, this inhibition being largely responsible for the anticoagulant action of heparin.
The proposed method is a one-step reaction based on a similar principle: as soon as factor Xa is added to the plasma-substrate mixture, two reactions take place simultaneously, namely,
- hydrolysis of the substrate by factor Xa
- inhibition of factor Xa by the heparin-antithrombin complex*.
After the necessary period of time for the competitive reaction to reach equilibrium, the quantity of paranitroaniline that is released is inversely proportional to the concentration of heparin present in the test medium.
- The heparin-antithrombin complex is made up from the heparin and the antithrombin (AT) peculiar to the patient.
2
Image /page/2/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a bold, sans-serif font, with a stylized graphic above it. The graphic appears to be an abstract shape, possibly representing a stylized leaf or a geometric design. The logo is simple and modern in appearance.
STA® - Multi Hep Calibrator >
The STA® - Multi Hep Calibrator reagents are lyophilized human plasmas at five different heparin concentrations. They are used to create the calibration curve on STA-R®, STA Compact®, and STA Satellite® analyzers performing the chromogenic method for heparin (UFH and LMWH) using STA® - Liquid Anti-Xa.
Three kinds of calibration are possible, depending on the type of molecule to be determined:
-
a calibration with the Reagents 1, 2, 3, 4 and 5 for UFH and/or LMWH assays,
-
a calibration with the Reagents 1, 2 and 4 dedicated to UFH assays,
-
a calibration with the Reagents 1, 3 and 5 dedicated to LMWH assays.
✓ STA® - Quality HNF/UFH
The STA® - Quality HNF/UFH reagents are lyophilized human plasmas at two different UFH concentrations. They are used for the quality control of UFH activity assay by measuring the anti-Xa activity using the chromogenic method STA® - Liquid Anti-Xa performed on STA-R®, STA Compact®, and STA Satellite® analyzers.
> STA® - Quality HBPM/LMWH
The STA® - Quality HBPM/LMWH reagents are lyophilized human plasmas at two different LMWH concentrations. They are used for the quality control of LMWH activity assay by measuring the anti-Xa activity using the chromogenic methods, STA® - Liquid Anti-Xa and STA® - Rotachrom® Heparin, performed on STA-R®, STA Compact, and STA Satellite® analyzers.
Statement of technological characteristics of the device compared to predicate devices
- STA® Liquid Anti-Xa is substantially equivalent to the predicate device, STA® V Rotachrom® Heparin (K010455) in indication/intended use, test principle, technology and performance thus yielding no new questions in safety and effectiveness.
- STA® Multi Hep Calibrator is substantially equivalent to the predicate devices, STA® -> Calibrator HBPM/LMWH Kit (K010350) and STA® - Hepanorm® H (K854762) in indication/intended use, technology and performance, thus yielding no new questions in safety and effectiveness.
The primary difference between the subject product and predicate devices is that the new calibrator kit is intended for use with both Unfractionated and Low Molecular Weight Heparin testing.
- STA® Quality HNF/UFH is substantially equivalent to the predicate device STA -> Heparin Control (K943520) in indication/intended use, technology and performance, thus yielding no new questions in safety and effectiveness.
3
Image /page/3/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with a stylized graphic above it. The graphic appears to be an abstract shape, possibly representing a stylized leaf or a geometric design. The logo is in black and white.
- STA® Quality HBPM/LMWH is substantially equivalent to the predicate device STA® -> HBPM/LMWH (K010324) in indication/intended use, technology and Quality performance, thus yielding no new questions in safety and effectiveness. The new STA® - Quality HBPM/LMWH is a modification to the current kit STA® - Quality HBPM/LMWH, the primary difference is that the new STA® - Quality HBPM/LMWH is intended for use with LMWH testing performed by STA® - Liquid Anti-Xa in addition to the current assay STA® - Rotachrom® Heparin (K010455).
Summary Performance Characteristics
- Precision >
Precision studies were performed according to the CLSI guideline EP5-A2 using samples containing heparin (22 days, 2 runs per day). The following results have been obtained:
| Hybrid calibration (5-point calibration) | | Sample 1
(UFH) | Sample 2
(UFH) | Sample 3
(UFH) | Sample 4
(LMWH) | Sample 5
(LMWH) | Sample 6
(LMWH) | |
|------------------------------------------|------|-------------------|-------------------|-------------------|--------------------|--------------------|--------------------|-------|
| Mean | $X¯$ | IU/mL | 0.21 | 0.55 | 0.97 | 0.86 | 1.48 | 1.75 |
| Repeatability | SD | IU/mL | 0.013 | 0.017 | 0.033 | 0.027 | 0.045 | 0.050 |
| | CV | % | 6.2 | 3.1 | 3.4 | 3.1 | 3.0 | 2.9 |
| Within-
laboratory
precision | SD | IU/mL | 0.021 | 0.036 | 0.053 | 0.041 | 0.075 | 0.087 |
| | CV | % | 9.9 | 6.6 | 5.5 | 4.8 | 5.1 | 5.0 |
| Dedicated calibration (3-point calibration) | | | Sample 1
(UFH) | Sample 2
(UFH) | Sample 3
(UFH) | Sample 4
(LMWH) | Sample 5
(LMWH) | Sample 6
(LMWH) |
|---------------------------------------------|----------------|-------|-------------------|-------------------|-------------------|--------------------|--------------------|--------------------|
| Mean | $\overline{X}$ | IU/mL | 0.22 | 0.55 | 0.97 | 0.86 | 1.48 | 1.75 |
| Repeatability | SD | IU/mL | 0.012 | 0.017 | 0.034 | 0.028 | 0.045 | 0.050 |
| | CV | % | 5.6 | 3.0 | 3.5 | 3.2 | 3.1 | 2.8 |
| Within-
laboratory
precision | SD | IU/mL | 0.020 | 0.033 | 0.050 | 0.045 | 0.078 | 0.089 |
| | CV | % | 9.2 | 6.1 | 5.1 | 5.2 | 5.3 | 5.1 |
- V Detection Limit - Working Range
The limit of detection and linearity were assessed for each method according to the CLSI quidelines EP17-A and EP6-A respectively.
In the UFH/LMWH method with the STA® - Multi Hep Calibrator (5-point calibration) the detection threshold on the STA-R® is 0.10 IU/ml (UFH and LMWH) and the linearity range extends to 1.10 IU/ml for the UFH and to 2.00 anti-Xa IU/ml for the LMWH. In the UFH method with the STA® - Multi Hep Calibrator (UFH 3-point calibration), the detection threshold on the STA-R® is 0.10 IU/ml and the linearity range extends to 1.10 IU/ml.
4
Image /page/4/Picture/0 description: The image shows the word "Stago" in a serif font, with each letter in lowercase except for the "S". Above the word is a stylized graphic that resembles a three-petal flower or a stylized letter "S". The logo is simple and clean, with a focus on the company name and a memorable visual element.
In the LMWH method with the STA® - Multi Hep Calibrator (LMWH,3-point calibration) the detection threshold on the STA-R® is 0.10 anti-Xa IU/ml and the linearity range extends to 2.00 anti-Xa IU/ml.
> Interfering substances
The STA® - Liquid Anti-Xa method (UFH and LMWH protocols) is insensitive to the following substances: hemoglobin (up to 1.5 g/l), conjugated bilirubin (up to 288 mg/l -342 µmol/), unconjugated bilirubin (up to 138 mg/l - 236 µmol/l) and triglycerides (up to 6.9 g/l - 8 mmol/l). The tests were performed according to the CLSI guideline EP7-A2.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/2 description: The image shows a seal for the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged around the left side of the circle. On the right side of the circle is an abstract symbol that resembles an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Diagnostica Stago, S.A.S. c/o Mr. Carlo d'Alessandro Director, IVD Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania, 10 Rome, Italy 00153
OCT 2 6 2011
Re: K111822
Trade/Device Name: STA®- Liquid Anti-Xa STA®-Multi Hep Calibrator STA®-Quality HNF/UFH STA®-HBPM/LMWH Regulation Number: 21 CFR § 864.7525 Regulation Name: Heparin Assay Regulatory Class: Class II Product Code: KFF; JIS; GGN Dated: September 22, 2011
Received: September 26, 2011
Dear Mr. d'Alessandro:
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 class II (Special Controls), 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
6
Page 2 – Mr. Carlo d'Alessandro
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 nredicate 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.h1m for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
tor
Leuch. S.
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Image /page/7/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with a stylized graphic above it. The graphic appears to be an abstract shape, possibly representing a stylized leaf or a curved, geometric form. The logo is simple and clean, with a focus on the company name and a distinctive visual element.
Indications for Use Statements 1.3
510(k) Number (if known): KII 1822
Device Name: STA® - Liquid Anti-Xa
Indications for Use:
The STA® - Liquid Anti-Xa kits are intended for use with STA-R®, STA Compact® and STA Satellite® analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
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 In Vitro Diagnostic Devices (OIVD)
Leve R. L.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111822
8
Image /page/8/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with a stylized graphic above it. The graphic appears to be three curved shapes arranged in a circular pattern, resembling a stylized flower or abstract design. The logo is black and white.
510(k) Number (if known): K111822
Device Name: STA® - Multi Hep Calibrator
Indications for Use:
The STA® - Multi Hep Calibrator is a set of calibrator plasmas intended for use with STA-R®, STA Compact® and STA Satellite® analyzers, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity.
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 In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111822
9
Image /page/9/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with a stylized graphic above it. The graphic appears to be three curved shapes arranged in a circular pattern, resembling a stylized eye or a partially opened flower. The logo is black and white.
510(k) Number (if known): K111822
Device Name: STA® - Quality HNF/UFH
Indications for Use:
The STA® - Quality HNF/UFH kit is a set of two plasmas intended for the quality control of unfractionated heparin (UFH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact® and STA Satellite® analyzers.
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 In Vitro Diagnostic Devices (OIVD)
Semt. L. Si.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111822
10
Image /page/10/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a sans-serif font, with a stylized graphic above it. The graphic appears to be composed of three curved shapes arranged in a circular fashion, creating a sense of movement or rotation.
510(k) Number (if known): K111822
Device Name: STA® - Quality HBPM/LMWH
Indications for Use:
The STA® - Quality HBPM/LMWH kit is a set of two plasmas intended for the quality control of low molecular weight heparin (LMWH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact® and STA Satellite® analyzers.
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 In Vitro Diagnostic Devices (OIVD)
Leach R.S.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111822