(441 days)
The STA® - Coag Control (N + 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).
The STA® - Coag Control (N + ABN) PLUS kit is a set of two control levels. Each kit provides: 12 x 2-ml vials of Reagent 1 (STA® - Coag Control N PLUS), citrated normal human plasma, lyophilized. 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).
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided document:
Device Name: STA® - Coag Control (N + ABN) PLUS
Device Intended Use: For the quality control of prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT) tests on STA-R® and STA Compact analyzers.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes "Precision" as the primary performance characteristic evaluated for this quality control device. The acceptance criteria are implicitly defined by the reported performance, as the study aims to demonstrate that the device performs equivalently to the predicate device and within acceptable analytical limits for precision in a clinical laboratory setting. While explicit numerical acceptance limits are not stated as "acceptance criteria," the study's results (CV%) are presented as demonstrating acceptable precision for a quality control material.
| Analyte (with Reagent) | Device Level | Test Statistic | Acceptance Criteria (Implicit) | Reported Performance (STA-R®) | Reported Performance (STA Compact®) |
|---|---|---|---|---|---|
| PT (in sec.) with STA®-Neoplastine® CI | N PLUS | Repeatability CV (%) | Acceptable analytical precision | 0.9 | 1.4 |
| Within-Lab precision CV (%) | Acceptable analytical precision | 1.1 | 2.3 | ||
| ABN PLUS | Repeatability CV (%) | Acceptable analytical precision | 0.6 | 0.7 | |
| Within-Lab precision CV (%) | Acceptable analytical precision | 2.0 | 2.1 | ||
| PT (in sec.) with STA®-Neoplastine® CI Plus | N PLUS | Repeatability CV (%) | Acceptable analytical precision | 0.9 | 1.5 |
| Within-Lab precision CV (%) | Acceptable analytical precision | 1.1 | 2.3 | ||
| ABN PLUS | Repeatability CV (%) | Acceptable analytical precision | 0.5 | 1.1 | |
| Within-Lab precision CV (%) | Acceptable analytical precision | 1.9 | 2.0 | ||
| APTT (in sec.) with STA®-C.K. Prest® | N PLUS | Repeatability CV (%) | Acceptable analytical precision | 0.6 | 1.2 |
| Within-Lab precision CV (%) | Acceptable analytical precision | 1.3 | 2.3 | ||
| ABN PLUS | Repeatability CV (%) | Acceptable analytical precision | 0.8 | 1.0 | |
| Within-Lab precision CV (%) | Acceptable analytical precision | 1.8 | 2.1 | ||
| APTT (in sec.) with STA®-Cephescreen® | N PLUS | Repeatability CV (%) | Acceptable analytical precision | 0.7 | 1.6 |
| Within-Lab precision CV (%) | Acceptable analytical precision | 2.1 | 2.3 | ||
| ABN PLUS | Repeatability CV (%) | Acceptable analytical precision | 0.7 | 1.1 | |
| Within-Lab precision CV (%) | Acceptable analytical precision | 1.9 | 1.8 | ||
| APTT (in sec.) with STA®-PTT A | N PLUS | Repeatability CV (%) | Acceptable analytical precision | 0.9 | 1.3 |
| Within-Lab precision CV (%) | Acceptable analytical precision | 2.6 | 3.1 | ||
| ABN PLUS | Repeatability CV (%) | Acceptable analytical precision | 1.0 | 0.8 | |
| Within-Lab precision CV (%) | Acceptable analytical precision | 1.9 | 1.7 | ||
| Fibrinogen (in g/l) with STA®-Fibrinogen | N PLUS | Repeatability CV (%) | Acceptable analytical precision | 2.4 | 4.1 |
| Within-Lab precision CV (%) | Acceptable analytical precision | 3.5 | 5.2 | ||
| ABN PLUS | Repeatability CV (%) | Acceptable analytical precision | 4.2 | 2.0 | |
| Within-Lab precision CV (%) | Acceptable analytical precision | 5.5 | 3.8 | ||
| TT (in sec.) with STA®-Thrombin | N PLUS | Repeatability CV (%) | Acceptable analytical precision | 2.4 | 1.3 |
| Within-Lab precision CV (%) | Acceptable analytical precision | 2.8 | 3.5 | ||
| ABN PLUS | Repeatability CV (%) | Acceptable analytical precision | 1.9 | 1.4 | |
| Within-Lab precision CV (%) | Acceptable analytical precision | 3.4 | 5.4 | ||
| AT (in %) with STA®-Stachrom® AT III | N PLUS | Repeatability CV (%) | Acceptable analytical precision | 1.9 | 2.7 |
| Within-Lab precision CV (%) | Acceptable analytical precision | 3.6 | 4.6 | ||
| ABN PLUS | Repeatability CV (%) | Acceptable analytical precision | 3.9 | 2.8 | |
| Within-Lab precision CV (%) | Acceptable analytical precision | 5.3 | 4.4 |
2. Sample Size Used for the Test Set and Data Provenance
- The precision studies were performed according to CLSI guideline EP5-A2.
- Sample Size: The STA® - Coag Control N PLUS and ABN PLUS were tested for 20 days, 2 runs per day, in duplicate. This means for each analyte and control level, there were 20 (days) * 2 (runs/day) * 2 (duplicates/run) = 80 measurements.
- Data Provenance: The document does not specify the country of origin of the data. It is a prospective study, as it describes a specific testing protocol conducted to evaluate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is a study evaluating the performance of a clinical laboratory quality control material, not a diagnostic device requiring expert interpretation of results. Therefore, the concept of "experts" establishing a "ground truth" for interpretation of test results is not applicable in the traditional sense. The "ground truth" for precision is the actual variability observed across repeated measurements, assessed using statistical methods.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation of data (e.g., medical images) to resolve discrepancies among experts. This study evaluates the quantitative precision of a laboratory control material, which does not involve subjective interpretation or adjudication among multiple reviewers.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This study evaluates the analytical performance (precision) of a quality control material used in in-vitro diagnostic assays, not the performance of an AI system, nor does it involve human readers or cases in the context of interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not an AI device or algorithm. The study evaluates the analytical performance of a quality control reagent on an automated analyzer. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.
7. The Type of Ground Truth Used
For this precision study, the "ground truth" is the statistical measure of variability (Coefficient of Variation, CV%) observed from repeated measurements of the control materials. There is no external "gold standard" or "definitive diagnosis" in the way one would refer to pathology for an imaging device. The performance is compared to generally accepted analytical performance standards for laboratory control materials and, implicitly, to the predicate device's expected precision.
8. The Sample Size for the Training Set
This study evaluates the analytical performance of a quality control material; it does not involve machine learning or a "training set" in the context of AI model development. The study is a direct performance evaluation.
9. How the Ground Truth for the Training Set Was Established
As noted above, this study does not involve a training set as it is not an AI device.
{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:
Page 1 of 4
{1}------------------------------------------------
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
{2}------------------------------------------------
Image /page/2/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, black shapes arranged in a circular pattern, creating a sense of motion or rotation.
| • 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 |
| NPLUS | ABNPLUS | NPLUS | ABNPLUS | |
|---|---|---|---|---|
| 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 DeviceSTA® - Coag Control(N + ABN) PLUS | Predicate DeviceSTA® - System Control N +PK943518 |
| Intended Use | For the quality control of thefollowing coagulation assays:prothrombin time (PT),activated partial thromboplastintime (APTT), fibrinogen,thrombin time (TT) andantithrombin (AT) in the normaland abnormal ranges. | Same, except:- additional analytes claimedfor the intended use in thenormal and abnormal ranges- the thrombin time isdetermined in the normal rangeonly. |
| Number of levelsper set | 2 (one normal and oneabnormal) | Same |
| Matrix | Citrated Human plasma | Same |
| Form | Lyophilized | Same |
| Reagentpreparation | Reconstitution with distilledwater | Same |
{3}------------------------------------------------
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 DeviceSTA® - Coag Control( N + ABN ) PLUS | Predicate DeviceSTA®-System Control N +PK943518 |
| Principle ofoperation | Used as controls for clottingassays (PT, APTT, fibrinogen,and TT) and chromogenicassays (AT) | Same |
| Analyzers | STA-R®STA Compact® | Same as well as STA Satellite® |
| Shelf-life | 24 months at 2-8 °C in intactvials | Same |
| Differences | ||
| Item | Subject DeviceSTA® - Coag Control( N + ABN ) PLUS | Predicate DeviceSTA® - System Control N +PK943518 |
| ReconstitutedReagent stability | 24 hours on-board analyzers | 8 hours on-board analyzers |
.
:
:
Carolina Career States
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.
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
{6}------------------------------------------------
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
§ 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.