(130 days)
The Pool Norm is a normal human plasma pool intended for use as a normal control for the activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT) assays carried out with the following tests:
- APTT: STA® - PTT A (REF 00595) on STA-R®, STA Compact® and STA Satellite® analyzers
- dRVVT: STA® - Staclot® dRVV Screen (REF 00339, 00333), STA® - Staclot® dRVV Confirm (REF 00334) on STA-R® and STA Compact® analyzers.
This reagent is to be used in clinical laboratories by certified medical laboratory personnel. For in vitro diagnostic use only. For prescription use.
Pool Norm is a lyophilized pool of at least 20 citrated normal human plasmas, containing buffer, stabilizers and preservatives.
The provided document describes the Pool Norm device, a normal human plasma pool intended for use as a normal control for activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT) assays. The study presented focuses on the device's precision performance.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the reported precision study. However, the study aims to demonstrate repeatability (within-run precision) and within-laboratory precision, which are standard measures for the performance of control materials. The reported performance is given as Standard Deviation (SD) in seconds and Coefficient of Variation (CV) in percentage for three different lots of Pool Norm on three different analyzer types.
Since explicit acceptance criteria are not provided, we will assume that the reported precision values are considered acceptable by the manufacturer for the intended use of the device. A common industry expectation for coagulation controls is a CV of less than 5% for within-laboratory precision, though this can vary. All reported CVs are well below this general benchmark.
| Assay | Analyzer Type | Sample Pool Norm Lot | Perfromance Metric | Reported Performance (SD (sec) / CV (%)) | (Assumed) Acceptance Criteria (Example) |
|---|---|---|---|---|---|
| STA® - PTT A | STA-R® | 110150 | Repeatability | 0.3 sec / 1.0 % | CV < 2% (Typical for APTT repeatability) |
| Within-Lab Precision | 0.6 sec / 1.7 % | CV < 5% (Typical for APTT W-L precision) | |||
| STA® - Staclot® dRVV Screen | STA-R® | 110150 | Repeatability | 0.3 sec / 0.8 % | CV < 2% (Typical for dRVVT repeatability) |
| Within-Lab Precision | 0.6 sec / 1.4 % | CV < 5% (Typical for dRVVT W-L precision) | |||
| STA® - Staclot® dRVV Confirm | STA-R® | 110150 | Repeatability | 0.3 sec / 0.8 % | CV < 2% (Typical for dRVVT repeatability) |
| Within-Lab Precision | 0.5 sec / 1.3 % | CV < 5% (Typical for dRVVT W-L precision) | |||
| STA® - PTT A | STA Compact® | 110150 | Repeatability | 0.5 sec / 1.6 % | CV < 2% |
| Within-Lab Precision | 0.7 sec / 2.1 % | CV < 5% | |||
| STA® - Staclot® dRVV Screen | STA Compact® | 110150 | Repeatability | 0.3 sec / 0.7 % | CV < 2% |
| Within-Lab Precision | 0.6 sec / 1.6 % | CV < 5% | |||
| STA® - Staclot® dRVV Confirm | STA Compact® | 110150 | Repeatability | 0.3 sec / 0.9 % | CV < 2% |
| Within-Lab Precision | 0.5 sec / 1.4 % | CV < 5% | |||
| STA® - PTT A | STA Satellite® | 110150 | Repeatability | 0.1 sec / 0.4 % | CV < 2% |
| Within-Lab Precision | 0.3 sec / 0.9 % | CV < 5% | |||
| Note: The "Assumed Acceptance Criteria" are typical industry benchmarks for precision of coagulation controls and are not explicitly stated in the document as acceptance criteria. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: For each lot of Pool Norm tested on each analyzer, "N" is reported as 80. The study was performed for 20 days, with 2 runs per day. This means 40 measurements per lot for repeatability (2 runs x 20 days) and 40 measurements per lot over 20 days for within-laboratory precision. The "N=80" stated in the tables likely refers to the total number of data points collected for the precision calculation (e.g., 2 runs/day * 20 days * 2 replicates per run or similar, though the details of the "N=80" are not fully elaborated beyond the 20 days, 2 runs per day). Given the context of a precision study, N=80 refers to the total number of individual measurements used for calculation within each lot and assay combination.
- Data Provenance: The study was "performed in-house". The company, Diagnostica Stago, is based in Gennevilliers, France. Therefore, the data provenance is likely retrospective (as it's a pre-submission study report) and from France (where the company is located).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this study. The "Pool Norm" device is a control material, not a diagnostic device that interprets patient data. The study is evaluating the precision (reproducibility) of the control material itself when used in coagulation assays. Ground truth in the sense of a clinical diagnosis or interpretation derived from expert review is not relevant here. The "ground truth", if one were to stretch the definition, would be the true, intrinsic coagulation activity of the plasma pool, which is measured by the assays.
4. Adjudication method for the test set
This information is not applicable. Since there is no "ground truth" based on expert interpretation, there is no need for an adjudication method. The study is a quantitative measurement of inherent device variability.
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
This information is not applicable. The device is a laboratory reagent (a normal human plasma pool for use as a control), not an AI-powered diagnostic imaging system or similar device that would involve human "readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a diagnostic reagent, and the study evaluates its precision, not an algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the concept of "ground truth" in the typical diagnostic sense is not applicable. The study assesses the inherent precision of the control material (Pool Norm) through repeated quantitative measurements in standard laboratory assays (APTT, dRVVT). The "true" value of the control's coagulation time is inherent to the material and is estimated by the mean (X) of the repeated measurements.
8. The sample size for the training set
This information is not applicable as there is no "training set" for this type of device. The study is a performance validation of a reagent, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set or clinical "ground truth" in this context.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol to the right of the text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the left side of the logo. The bird symbol is composed of three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12, 2014
Diagnostica Stago Ms. Marie Compagnon-Riobe Registration & Reagent Documentation Manager 125 Avenue Louis Roche 92230 Gennevilliers, France
Re: K142132
Trade/Device Name: Pool Norm Plasma Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: GGN Dated: November 4, 2014 Received: November 6, 2014
Dear Ms. Compagnon-Riobe:
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 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); 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
{1}------------------------------------------------
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 regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. 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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K142132
Device Name POOL NORM
Indications for Use (Describe)
The Pool Norm is a normal human plasma pool intended for use as a normal control for the activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT) assays carried out with the following tests:
- APTT: STA® - PTT A (REF 00595) on STA-R®, STA Compact® and STA Satellite® analyzers - dRVVT: STA® - Staclot® dRVV Screen (REF 00339, 00333), STA® - Staclot® dRVV Confirm (REF 00334) on STA-R® and STA Compact® analyzers.
This reagent is to be used in clinical laboratories by certified medical laboratory personnel. For in vitro diagnostic use only. For prescription use.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | ||
|---|---|---|
| Submitter's Information: | Diagnostica Stago S.A.S. | |
| 125 avenue Louis Roche | ||
| 92230 Gennevilliers | ||
| France | ||
| Contact Person: | Marie Compagnon-Riobé | |
| Registration Manager and Regulatory Affairs Coordinator | ||
| Phone: 011-33- 1 41 47 16 11 | ||
| Fax: 011-33- 1 41 47 57 50 | ||
| Date Prepared: | December 12th, 2014 | |
| Device Name: | Pool Norm | |
| Device Classification: | Class IIRegulation Number: 21 CFR 864.5425Panel: Hematology (81)Product Code: GGN | |
| Predicate Devices: | - Pooled Normal Plasma - Pre-amendment deviceGeorge King Bio-Medical, INC- STA® - Control LA 1 - K061803Diagnostica Stago | |
| Device Intended Use: | The Pool Norm is a normal human plasma pool intended foruse as a normal control for the activated partialthromboplastin time (APTT) and dilute Russell's viper venomtime (dRVVT) assays carried out with the following tests: | |
| - APTT: STA® - PTT A (REF 00595) on STA-R®, STACompact® and STA Satellite® analyzers | ||
| - dRVVT: STA® - Staclot® dRVV Screen (REF 00339,00333), STA® - Staclot® dRVV Confirm (REF 00334) onSTA-R® and STA Compact® analyzers. | ||
| This reagent is to be used in clinical laboratories by certifiedmedical laboratory personnel. For in vitro diagnostic useonly. For prescription use. | ||
| Device Description: | Pool Norm is a lyophilized pool of at least 20 citrated normalhuman plasmas, containing buffer, stabilizers andpreservatives. |
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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 the first letter capitalized and the rest in lowercase. Above the word "Stago" is an abstract graphic element. The graphic element appears to be composed of two shapes, one in a reddish-brown color and the other in a grayish-brown color, arranged in a way that suggests a stylized, incomplete circle or a stylized eye.
510(k) Summary
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with the letters in a reddish-brown color. Above the word is an abstract graphic element, also in reddish-brown and gray. The graphic element appears to be two curved shapes, one red and one gray, that are positioned to suggest movement or flow.
Summary of precision performance data
Repeatability/Within- Laboratory Precision Study was performed in-house according to the CLSI guideline document EP05-A2 (3). Pool Norm was tested for 20 days, 2 runs per day. Test data are presented below:
- on STA-R®
| Assay | SamplePool NormLot | N | X(sec) | Repeatability | Within-LaboratoryPrecision | ||
|---|---|---|---|---|---|---|---|
| SD(sec) | CV(%) | SD(sec) | CV(%) | ||||
| STA® - PTT A | 110150110795111289 | 80 | 33.132.632.5 | 0.30.30.3 | 1.01.00.9 | 0.60.50.5 | 1.71.61.5 |
| STA® - Staclot®dRVV Screen | 110150110795111289 | 80 | 42.441.641.2 | 0.30.20.2 | 0.80.60.4 | 0.60.50.5 | 1.41.31.1 |
| STA® - Staclot®dRVV confirm | 110150110795111289 | 80 | 38.237.937.7 | 0.30.30.3 | 0.80.80.7 | 0.50.50.4 | 1.31.31.1 |
- on STA Compact®
| Assay | SamplePool NormLot | N | X(sec) | Repeatability | Within-LaboratoryPrecision | ||
|---|---|---|---|---|---|---|---|
| SD(sec) | CV(%) | SD(sec) | CV(%) | ||||
| STA® - PTT A | 110150 | 80 | 33.0 | 0.5 | 1.6 | 0.7 | 2.1 |
| 110795 | 32.7 | 0.4 | 1.2 | 0.6 | 1.7 | ||
| 111289 | 32.5 | 0.5 | 1.5 | 0.7 | 2.1 | ||
| STA® - Staclot®dRVV Screen | 110150 | 80 | 40.5 | 0.3 | 0.7 | 0.6 | 1.6 |
| 110795 | 40.0 | 0.3 | 0.7 | 0.6 | 1.4 | ||
| 111289 | 39.4 | 0.4 | 0.9 | 0.7 | 1.8 | ||
| STA® - Staclot®dRVV confirm | 110150 | 80 | 37.0 | 0.3 | 0.9 | 0.5 | 1.4 |
| 110795 | 36.5 | 0.5 | 1.4 | 0.7 | 1.9 | ||
| 111289 | 36.4 | 0.4 | 1.0 | 0.5 | 1.4 |
- on STA Satellite®
| Assay | SamplePool NormLot | N | X(sec) | Repeatability | Within-LaboratoryPrecision | ||
|---|---|---|---|---|---|---|---|
| SD(sec) | CV(%) | SD(sec) | CV(%) | ||||
| 110150 | 33.5 | 0.1 | 0.4 | 0.3 | 0.9 | ||
| STA® - PTT A | 110795 | 80 | 33.1 | 0.1 | 0.2 | 0.3 | 0.9 |
| 111289 | 33.1 | 0.1 | 0.3 | 0.3 | 0.9 |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with the letters in a reddish-brown color. Above the word "Stago" is an abstract symbol that appears to be composed of two curved shapes, one in a reddish-brown color and the other in a grayish-brown color. The symbol is positioned to suggest movement or flow.
Substantial Equivalence Comparison Table:
| Attributes orCharacteristics | Pool Norm(Diagnostica Stago)Subject device | Pooled Normal Plasma(George King Bio-Medical)Predicate device | STA® - Control LA 1(Diagnostica Stago)Predicate device |
|---|---|---|---|
| Intended Use | Normal control for theactivated partialthromboplastin time(APTT) and diluteRussell's viper venomtime (dRVVT) assayscarried out with thefollowing tests:- APTT: STA® - PTT A(REF 00595) on STA-R®, STA Compact® andSTA Satellite® analyzers- dRVVT: STA® -Staclot® dRVV Screen(REF 00339, 00333),STA® - Staclot® dRVVConfirm (REF 00334) onSTA-R® and STACompact® analyzers.This reagent is to be usedin clinical laboratories bycertified medicallaboratory personnel. Forin vitro diagnostic useonly. For prescriptionuse. | Control plasma intendedto be used to monitorcoagulation tests.For in vitro diagnosticuse only. | Lupus anticoagulant(LA) negative plasmaintended for the qualitycontrol of the tests forLA detection carried outwith the followingtests:- STA® - Staclot® dRVVScreen (REF 00339,00333)- STA® - Staclot® dRVVConfirm (REF 00334)Staclot® LA (REF00600, 00594).For in vitro diagnosticuse only. |
| Assay valuesreporting | Lot-specific Certificateof analysis:- reporting assay valuesfor Activated PartialThromboplastin Time(APTT),- certifying negativetesting for lupusanticoagulant. | Lot-specific Certificateof analysis:- reporting assay valuesfor Prothrombin Time(PT), Activated PartialThromboplastin Time(APTT), Fibrinogen,Factors V, VII, VIII, IX,X, XI and XII | Lot-specific Certificateof analysis:- reporting controlvalues forSTA® - Staclot® dRVVScreen, STA® - Staclot®dRVV Confirm andStaclot® LA |
| Test procedure | Same manner as patients'samples | Same | Automatically used bythe instruments |
| Matrix | Pooled citrated humanplasma from normaldonors | Same | LA negative citratedhuman plasma |
| Form | Lyophilized | Frozen | Lyophilized |
| Attributes orCharacteristics | Pool Norm(Diagnostica Stago)Subject device | Pooled Normal Plasma(George King Bio-Medical)Predicate device | STA® - Control LA 1(Diagnostica Stago)Predicate device |
| In-use stability | 8 hours at 20 ± 5 °C | 2 hours after beingthawed at 37 °C | *8 hours at 20 ± 5 °C*8 hours on the STACompact® and STA-R® |
| AnatomicalSites | Not applicable. No directpatient contact | Same | Same |
| Storage | 2-8 °C | ≤ - 70 °C | 2-8 °C |
| Sterility | No sterility requirements.No direct patient contact | Same | Same |
| Biocompatibility | No biocompatibilityrequirements. No directpatient contact | Same | Same |
| Chemical Safety | No issues regardingchemical safety due to nodirect patient contact | Same | Same |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Stago. The logo features the word "Stago" in a red, serif font. Above the word is an abstract graphic consisting of two curved shapes, one red and one gray, arranged in a circular fashion. The red shape is larger and positioned above the gray shape.
§ 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.