(130 days)
No
The document describes a normal human plasma pool used as a control for laboratory assays. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The "Pool Norm" is stated to be "For in vitro diagnostic use only" and its purpose is to serve as a normal control for laboratory assays, not to treat or diagnose patients.
No
This device is described as a "normal human plasma pool intended for use as a normal control" for specific assays. It is used to control the performance of diagnostic tests, not to perform a diagnosis itself. The text states "For in vitro diagnostic use only," which refers to the environment in which it's used with other diagnostic instruments, but the device itself is a control reagent.
No
The device is a lyophilized pool of human plasma, which is a biological reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Intended Use: The device is intended to be used as a normal control for specific laboratory assays (APTT and dRVVT) performed on human plasma samples. This is a classic function of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- User and Setting: It is intended for use in clinical laboratories by certified medical laboratory personnel, which is the typical setting for IVD use.
- Device Description: The description of the device as a "lyophilized pool of at least 20 citrated normal human plasmas" is consistent with the composition of many IVD control materials.
- Performance Studies: The inclusion of performance studies (Repeatability/Within- Laboratory Precision Study) is a requirement for demonstrating the reliability and suitability of an IVD for its intended use.
- Predicate Device: The mention of predicate devices, including a "Pre-amendment device" and a device with a K number (K061803), indicates that this device is being compared to or is similar to other devices that have been cleared or approved as IVDs.
All of these factors strongly indicate that the Pool Norm is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GGN
Device Description
Pool Norm is a lyophilized pool of at least 20 citrated normal human plasmas, containing buffer, stabilizers and preservatives.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not applicable. No direct patient contact
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This reagent is to be used in clinical laboratories by certified medical laboratory personnel.
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)
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.
On STA-R®:
STA® - PTT A: 3 lots (110150, 110795, 111289), N=80 for each lot. X values (sec) were 33.1, 32.6, 32.5. Repeatability SD (sec) were 0.3, 0.3, 0.3, with CV (%) 1.0, 1.0, 0.9. Within-Laboratory Precision SD (sec) were 0.6, 0.5, 0.5, with CV (%) 1.7, 1.6, 1.5.
STA® - Staclot® dRVV Screen: 3 lots (110150, 110795, 111289), N=80 for each lot. X values (sec) were 42.4, 41.6, 41.2. Repeatability SD (sec) were 0.3, 0.2, 0.2, with CV (%) 0.8, 0.6, 0.4. Within-Laboratory Precision SD (sec) were 0.6, 0.5, 0.5, with CV (%) 1.4, 1.3, 1.1.
STA® - Staclot® dRVV confirm: 3 lots (110150, 110795, 111289), N=80 for each lot. X values (sec) were 38.2, 37.9, 37.7. Repeatability SD (sec) were 0.3, 0.3, 0.3, with CV (%) 0.8, 0.8, 0.7. Within-Laboratory Precision SD (sec) were 0.5, 0.5, 0.4, with CV (%) 1.3, 1.3, 1.1.
On STA Compact®:
STA® - PTT A: 3 lots (110150, 110795, 111289), N=80 for each lot. X values (sec) were 33.0, 32.7, 32.5. Repeatability SD (sec) were 0.5, 0.4, 0.5, with CV (%) 1.6, 1.2, 1.5. Within-Laboratory Precision SD (sec) were 0.7, 0.6, 0.7, with CV (%) 2.1, 1.7, 2.1.
STA® - Staclot® dRVV Screen: 3 lots (110150, 110795, 111289), N=80 for each lot. X values (sec) were 40.5, 40.0, 39.4. Repeatability SD (sec) were 0.3, 0.3, 0.4, with CV (%) 0.7, 0.7, 0.9. Within-Laboratory Precision SD (sec) were 0.6, 0.6, 0.7, with CV (%) 1.6, 1.4, 1.8.
STA® - Staclot® dRVV confirm: 3 lots (110150, 110795, 111289), N=80 for each lot. X values (sec) were 37.0, 36.5, 36.4. Repeatability SD (sec) were 0.3, 0.5, 0.4, with CV (%) 0.9, 1.4, 1.0. Within-Laboratory Precision SD (sec) were 0.5, 0.7, 0.5, with CV (%) 1.4, 1.9, 1.4.
On STA Satellite®:
STA® - PTT A: 3 lots (110150, 110795, 111289), N=80 for each lot. X values (sec) were 33.5, 33.1, 33.1. Repeatability SD (sec) were 0.1, 0.1, 0.1, with CV (%) 0.4, 0.2, 0.3. Within-Laboratory Precision SD (sec) were 0.3, 0.3, 0.3, with CV (%) 0.9, 0.9, 0.9.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
- Pooled Normal Plasma - Pre-amendment device, STA® - Control LA 1 - K061803
Reference Device(s)
STA® - Control LA 1 - K061803
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 II | |
| Regulation Number: 21 CFR 864.5425 | ||
| Panel: Hematology (81) | ||
| Product Code: GGN | ||
| Predicate Devices: | - Pooled Normal Plasma - Pre-amendment device | |
| George King Bio-Medical, INC |
- STA® - Control LA 1 - K061803
Diagnostica Stago | |
| Device Intended Use: | 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. | |
| Device Description: | Pool Norm is a lyophilized pool of at least 20 citrated normal
human plasmas, containing buffer, stabilizers and
preservatives. | |
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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
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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 | Sample
Pool Norm
Lot | N | X
(sec) | Repeatability | | Within-
Laboratory
Precision | |
|---------------------------------|----------------------------|----|----------------------|-------------------|-------------------|------------------------------------|-------------------|
| | | | | SD
(sec) | CV
(%) | SD
(sec) | CV
(%) |
| STA® - PTT A | 110150
110795
111289 | 80 | 33.1
32.6
32.5 | 0.3
0.3
0.3 | 1.0
1.0
0.9 | 0.6
0.5
0.5 | 1.7
1.6
1.5 |
| STA® - Staclot®
dRVV Screen | 110150
110795
111289 | 80 | 42.4
41.6
41.2 | 0.3
0.2
0.2 | 0.8
0.6
0.4 | 0.6
0.5
0.5 | 1.4
1.3
1.1 |
| STA® - Staclot®
dRVV confirm | 110150
110795
111289 | 80 | 38.2
37.9
37.7 | 0.3
0.3
0.3 | 0.8
0.8
0.7 | 0.5
0.5
0.4 | 1.3
1.3
1.1 |
- on STA Compact®
| Assay | Sample
Pool Norm
Lot | N | X
(sec) | Repeatability | | Within-
Laboratory
Precision | |
|---------------------------------|----------------------------|----|------------|---------------|-----------|------------------------------------|-----------|
| | | | | 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 | Sample
Pool Norm
Lot | N | X
(sec) | Repeatability | | Within-
Laboratory
Precision | |
|--------------|----------------------------|----|------------|---------------|-----------|------------------------------------|-----------|
| | | | | 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 |
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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 or
Characteristics | 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 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. | Control plasma intended
to be used to monitor
coagulation tests.
For in vitro diagnostic
use only. | Lupus anticoagulant
(LA) negative plasma
intended for the quality
control of the tests for
LA detection carried out
with the following
tests: - STA® - Staclot® dRVV
Screen (REF 00339,
- STA® - Staclot® dRVV
Confirm (REF 00334)
Staclot® LA (REF
00600, 00594).
For in vitro diagnostic
use only. |
| Assay values
reporting | Lot-specific Certificate
of analysis: - reporting assay values
for Activated Partial
Thromboplastin Time
(APTT), - certifying negative
testing for lupus
anticoagulant. | Lot-specific Certificate
of analysis: - reporting assay values
for Prothrombin Time
(PT), Activated Partial
Thromboplastin Time
(APTT), Fibrinogen,
Factors V, VII, VIII, IX,
X, XI and XII | Lot-specific Certificate
of analysis: - reporting control
values for
STA® - Staclot® dRVV
Screen, STA® - Staclot®
dRVV Confirm and
Staclot® LA |
| Test procedure | Same manner as patients'
samples | Same | Automatically used by
the instruments |
| Matrix | Pooled citrated human
plasma from normal
donors | Same | LA negative citrated
human plasma |
| Form | Lyophilized | Frozen | Lyophilized |
| Attributes or
Characteristics | 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 being
thawed at 37 °C | *8 hours at 20 ± 5 °C
*8 hours on the STA
Compact® and STA-R® |
| Anatomical
Sites | Not applicable. No direct
patient contact | Same | Same |
| Storage | 2-8 °C | ≤ - 70 °C | 2-8 °C |
| Sterility | No sterility requirements.
No direct patient contact | Same | Same |
| Biocompatibility | No biocompatibility
requirements. No direct
patient contact | Same | Same |
| Chemical Safety | No issues regarding
chemical safety due to no
direct patient contact | Same | Same |
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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.