(441 days)
Not Found
No
The device is a control material for coagulation analyzers and the description focuses on its composition and performance characteristics, with no mention of AI or ML.
No
The device is a quality control material for in vitro diagnostic tests of coagulation parameters, not a device used for treating patients.
No
Explanation: The device is a "kit containing a normal plasma and an abnormal plasma intended for the quality control of the following tests on STA-R® and STA Compact analyzers." It is a control material used to assess the performance of diagnostic tests, not a diagnostic device itself that directly diagnoses a condition.
No
The device is a kit containing lyophilized plasma, which is a physical substance, not software. It is a control material for in vitro diagnostic tests performed on hardware analyzers.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended for the quality control of the following tests on STA-R® and STA Compact analyzers: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT)." These are all in vitro diagnostic tests performed on patient samples.
- Device Description: The device is a "kit containing a normal plasma and an abnormal plasma" which are used as "controls for clotting assays (PT, APTT, fibrinogen, and TT) and chromogenic assays (AT) performed on analyzers of the STA® line." Control materials are a fundamental component of in vitro diagnostic testing to ensure the accuracy and reliability of the results.
- Performance Studies: The document describes "Precision studies" performed according to CLSI guidelines, which are standard practices for evaluating the performance of IVD devices and their associated control materials.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K943518) indicates that this device is being compared to a previously cleared IVD device.
While the device itself is a control material and not the analyzer performing the test, it is an essential component used in vitro to ensure the quality and accuracy of the diagnostic tests performed on patient samples. Therefore, it falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STA - Coag Control @ +ABN) PLUS is a kit containing assayed normal and abnormal plasmas intended for the quality control of the following quantitative tests on STA-R and STA Compact analyzers: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT).
Product codes (comma separated list FDA assigned to the subject device)
GGN
Device Description
The STA® - Coag Control (N + ABN) PLUS kit is a set of two control levels. Each kit provides: o 12 x 2-ml vials of Reagent 1 (STA® - Coag Control N PLUS), citrated normal human plasma, lyophilized. 0 12 x 2-ml vials of Reagent 2 (STA® - Coag Control |ABN PLUS), citrated abnormal human plasma, lyophilized. STA® - Coag Control (N+ |ABN) PLUS Reagents are used as controls for clotting assays (PT, APTT, fibrinogen, and TT) and chromogenic assays (AT) performed on analyzers of the STA® line. Analyzers of the STA® line utilize the chronometric principle (viscosity based detection system) for clotting tests while the chromogenic assays are based on the photometric method (measurement of absorbance of monochromatic light).
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)
Precision studies were performed according to the CLSI guideline EPS-A2. STA - Coag Control N PLUS and ABN PLUS were tested for 20 days, 2 runs per day, in duplicate on STA-R and STA Compact.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Repeatability CV(%) and Within-Laboratory precision CV (%) for PT, APTT, Fibrinogen, TT, and AT.
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.
STA® - System Control N + P - K943518
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
§ 864.5425 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
KiZOOIY.
Image /page/0/Picture/1 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a simple, sans-serif font, with a stylized graphic above it. The graphic is a circular shape with three curved segments removed, creating a dynamic and modern design.
MAR 1 4 2013
510(k) Summary
Submitter's Information
Diagnostica Stago, Inc. Five Century Drive Parsippany, New Jersey 07054
Phone Number: 973 631-1200 Fax Number: 973 867-6859
Date Prepared: March 1, 2013
Contact Person:
Delphine Ysvelain
Regulatory Affairs Manager
Device Name: STA® - Coag Control (N + ABN) PLUS
Device Classification: Class II
Regulation Number: 21 CFR 864.5425 Panel: Hematology (81) Product Code: GGN
Predicate Device: STA® - System Control N + P - K943518 Manufacturer: Diagnostica Stago (Formerly known as American Bioproducts)
Device Intended Use:
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Image /page/1/Picture/0 description: The image shows the word "Stago" in a serif font, with the "S" capitalized and the rest of the letters in lowercase. Above the word "Stago" is a stylized graphic element. The graphic element appears to be composed of three curved shapes arranged in a circular or triangular pattern, with each shape being black and solid.
The STA - Coag Control @ +ABN) PLUS is a kit containing assayed normal and abnormal plasmas intended for the quality control of the following quantitative tests on STA-R and STA Compact analyzers: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT).
Device description:
The STA® - Coag Control (N + ABN) PLUS kit is a set of two control levels.
Each kit provides:
o 12 x 2-ml vials of Reagent 1 (STA® - Coag Control N PLUS), citrated normal human plasma, lyophilized.
0 12 x 2-ml vials of Reagent 2 (STA® - Coag Control |ABN PLUS), citrated abnormal human plasma, lyophilized.
STA® - Coag Control (N+ |ABN) PLUS Reagents are used as controls for clotting assays (PT, APTT, fibrinogen, and TT) and chromogenic assays (AT) performed on analyzers of the STA® line.
Analyzers of the STA® line utilize the chronometric principle (viscosity based detection system) for clotting tests while the chromogenic assays are based on the photometric method (measurement of absorbance of monochromatic light).
Statement of technological characteristics of the device compared to predicate device:
STA® - Coag Control (N+ ABN) PLUS is substantially equivalent to its predicate device, STA® - System Control N + B (K943518), based on similar intended use, technology and principles of operation, thus yielding no new questions in safety, effectiveness or technology.
Summary Performance Characteristics
Precision
Precision studies were performed according to the CLSI guideline EPS-A2. STA - Coag Control N PLUS and ABN PLUS were tested for 20 days, 2 runs per day, in duplicate on STA-R and STA Compact .
The following results have been obtained
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| • on STA-R® | Repeatability CV(%) | Within-Laboratory precision CV (%) | ||
|---|---|---|---|---|
| N PLUS | ABN PLUS | N PLUS | ABN PLUS | |
| PT (in sec.) | ||||
| with STA®- Neoplastine® CI | 0.9 | 0.6 | 1.1 | 2.0 |
| PT (in sec.) | ||||
| with STA®- Neoplastine® CI Plus | 0.9 | 0.5 | 1.1 | 1.9 |
| APTT (in sec.) | ||||
| with STA®- C.K. Prest® | 0.6 | 0.8 | 1.3 | 1.8 |
| APTT (in sec.) | ||||
| with STA®- Cephescreen® | 0.7 | 0.7 | 2.1 | 1.9 |
| APTT (in sec.) | ||||
| with STA®- PTT A | 0.9 | 1.0 | 2.6 | 1.9 |
| Fibrinogen (in g/l) | ||||
| with STA®- Fibrinogen | 2.4 | 4.2 | 3.5 | 5.5 |
| TT (in sec.) | ||||
| with STA®- Thrombin | 2.4 | 1.9 | 2.8 | 3.4 |
| AT (in %) | ||||
| with STA®- Stachrom® AT III | 1.9 | 3.9 | 3.6 | 5.3 |
| • on STA Compact® | Repeatability CV (%) | Within-Laboratory precision CV (%) | ||
| N PLUS | ABN PLUS | N PLUS | ABN PLUS |
| | N
PLUS | ABN
PLUS | N
PLUS | ABN
PLUS |
|-----------------------------------------------------------------------|-----------|-------------|-----------|-------------|
| PT (In sec.)
with STA ® - Neoplastine® Cl | 1.4 | 0.7 | 2.3 | 2.1 |
| PT (In sec.)
with STA ® - Neoplastine® Cl Plus | 1.5 | 1.1 | 2.3 | 2.0 |
| APTT (In sec.)
with STA ® - C.K. Prest® | 1.2 | 1.0 | 2.3 | 2.1 |
| APTT (In sec.)
with STA ® - Cephascreen® | 1.6 | 1.1 | 2.3 | 1.8 |
| APTT (In sec.)
with STA ® - PTT [Image: square with diagonal line] | 1.3 | 0.8 | 3.1 | 1.7 |
| Fibrinogen (In g/l)
with STA ® - Fibrinogen | 4.1 | 2.0 | 5.2 | 3.8 |
| TT (In sec.)
with STA ® - Thrombin | 1.3 | 1.4 | 3.5 | 5.4 |
| AT (In %)
with STA ® - Stachrom® AT III | 2.7 | 2.8 | 4.6 | 4.4 |
Substantial Equivalence Comparison Table:
:
.
. .
.
.
| Similarities | ||
|---|---|---|
| Item | Subject Device | |
| STA® - Coag Control | ||
| (N + ABN) PLUS | Predicate Device | |
| STA® - System Control N + | ||
| P | ||
| K943518 | ||
| Intended Use | For the quality control of the | |
| following coagulation assays: | ||
| prothrombin time (PT), | ||
| activated partial thromboplastin | ||
| time (APTT), fibrinogen, | ||
| thrombin time (TT) and | ||
| antithrombin (AT) in the normal | ||
| and abnormal ranges. | Same, except: |
- additional analytes claimed
for the intended use in the
normal and abnormal ranges - the thrombin time is
determined in the normal range
only. |
| Number of levels
per set | 2 (one normal and one
abnormal) | Same |
| Matrix | Citrated Human plasma | Same |
| Form | Lyophilized | Same |
| Reagent
preparation | Reconstitution with distilled
water | Same |
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Image /page/3/Picture/0 description: The image shows the word "Stago" in a serif font, with the first letter capitalized and the rest in lowercase. Above the word is a stylized graphic element that resembles a crescent shape with a small gap, creating a sense of movement or rotation. The logo is simple and clean, with a focus on the text and the abstract symbol above it.
| Similarities | ||
|---|---|---|
| Item | Subject Device | |
| STA® - Coag Control | ||
| ( N + ABN ) PLUS | Predicate Device | |
| STA®-System Control N + | ||
| P | ||
| K943518 | ||
| Principle of | ||
| operation | Used as controls for clotting | |
| assays (PT, APTT, fibrinogen, | ||
| and TT) and chromogenic | ||
| assays (AT) | Same | |
| Analyzers | STA-R® | |
| STA Compact® | Same as well as STA Satellite® | |
| Shelf-life | 24 months at 2-8 °C in intact | |
| vials | Same | |
| Differences | ||
| Item | Subject Device | |
| STA® - Coag Control | ||
| ( N + ABN ) PLUS | Predicate Device | |
| STA® - System Control N + | ||
| P | ||
| K943518 | ||
| Reconstituted | ||
| Reagent stability | 24 hours on-board analyzers | 8 hours on-board analyzers |
.
:
:
Carolina Career States
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2013
Diagnostica Stago, Inc. c/o Ms. Delphine Ysvelain Regulatory Affairs Associate 5 Century Drive Parsippany, New Jersey 07054
Re: K120014
Trade/Device Name: STA® - Coag Control (N + ABN) PLUS Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN Dated: March 6, 2013 Received: March 7, 2013
Dear Ms. Ysvelain:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
5
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Maria M. Chan -S
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Image /page/6/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a simple, sans-serif font, with a stylized graphic above it. The graphic is a circular shape with three curved segments removed, creating a dynamic, almost floral appearance. The logo is simple and modern.
10.0 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K120014
Device Name: STA® - Coag Control (N + ABN) PLUS
Indications for Use:
The STA® - Coag Control @ + ABN) PLUS is a kit containing a normal plasma and an abnormal plasma intended for the quality control of the following tests on STA-R® and STA Compact analyzers: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT).
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) .
Leonthena R. Carrington -S
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)__K120014