(187 days)
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No
The device description and performance studies focus on a physical membrane system and capillary tube for blood cell separation, with no mention of AI or ML.
No
The device is described as a "sample preparation aid" for in vitro diagnostic testing, specifically for separating blood components to allow for diagnostic analysis. It does not treat or diagnose a medical condition in a patient.
No
The device is a sample preparation aid for diagnostic testing systems, not a diagnostic device itself.
No
The device description explicitly states that the Blood Cell Separator consists of two physical components: a membrane system and a capillary tube. This indicates it is a hardware device, not software-only.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for use as a "sample preparation aid to in vitro Lithium colorimetric diagnostic testing systems". The term "in vitro diagnostic testing systems" is a key indicator of an IVD.
- Device Description: The description further clarifies its role in preparing a sample (serum or plasma) from a whole blood specimen for use in these diagnostic tests.
- Performance Studies: The "Summary of Performance Studies" details analytical performance evaluations related to its use in preparing samples for lithium diagnostic testing, including precision, comparison to a routine cell separating technique, and assay sensitivity. These are typical studies conducted for IVD devices or components used in IVD workflows.
- Predicate Device(s): The listed predicate devices are "BD Vacutainer® Brand Tube for the Determinations Requiring Serum" and "BD Vacutainer® Brand Tube for Hematology and Selective Chemistry Determinations". These are also devices used in the collection and preparation of samples for in vitro diagnostic testing.
While the device itself doesn't perform the diagnostic test, it is a crucial component in the sample preparation step of an in vitro diagnostic process. Therefore, it falls under the definition of an IVD device.
N/A
Intended Use / Indications for Use
The Blood Cell Separator is intended for the use as a sample preparation aid to in vitro Lithium colorimetric diagnostic testing systems where a precise, micro-volume sample of serum or plasma is required to be collected from a whole blood specimen. The liquid produced by the device is dependent upon the sample collected; whole blood collected with an anti-coagulant will produce plasma, and whole blood collected without an anti-coagulant will produce serum.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
The Blood Cell Separator is intended for use as a sample preparation aid in in vitro lithium colorimetric diagnostic testing systems where a precise, micro-volume sample of serum or plasma is required to be collected from a whole blood specimen.
The Blood Cell Separator consists of two components packaged in a single separator device: the membrane system and a capillary tube. The device is based upon a multiple layer membrane system designed to separate blood cells and serum/plasma. This is achieved through the attraction and capture of blood cells from a whole blood specimen applied to the surface of the membrane system. The residual liquid continues to flow laterally to the tip of the membrane at which time the capillary tube fills vertically to the pipette's fixed, controlled volume and is ready to use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Studies were performed to evaluate the analytical performance of the Blood Cell Separator as an aid in preparing a sample for lithium colorimetric diagnostic testing analysis.
The precision standard deviation (SD) ranged from 0.04 to 0.11 mEg/L when samples were assayed in multiple runs over multiple days for both EDTA plasma and serum. Using serum, the percent coefficient of variation (%CV) of a control at ~ 1.5 mEq/L lithium was 6.4% when tested in 50 runs over five days (10 runs per day). Using EDTA plasma, the percent coefficient of variation (%CV) of a control at ~ 0.8 mEq/L lithium was 6.7% when tested in 30 runs over three days (10 runs per day).
The Blood Cell Separator was compared to a routine cell separating technique. Results were listed as total cells per High Powered Field (HPF). The summary data reflected that either method provides a liquid sample containing no blood cells.
The assay sensitivity was 0.03 mEq/L with BD Vacutainer Tube EDTA Plasma Separation and 0.03 mEq/L using the Akers Blood Cell Separation method illustrating equivalent performance.
The daily standard deviation obtained during the five (5) day precision study for the blood cell separator ranged from 0.01 mEq/L to 0.04 mEq/L for the low value sample and 0.03mEq/L to 0.07 mEq/L for the high value sample compared to daily standard deviations for the BD vacutainer system of 0.03 mEq/L to 0.08 mEq/L and 0.03 mEq/L to 0.08 mEq/L respectively for the low and high value samples. The composite percent coefficient of variation (%CV) for the blood cell separator system based on 50 samples over 5 days was 8.4% for the low value sample and 5.7% for the high value sample compared to 9.5% and 6.1%, respectively for the BD vacutainer system. These results illustrated a highly favorable precision performance of the blood cell separator system when compared to the BD vacutainer system.
The recovery correlation yielded an R value of 0.993 and an Re value of 0.9866 illustrating very tight correlation between the two pathways.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision: SD ranged from 0.04 to 0.11 mEg/L. %CV of a control at ~ 1.5 mEq/L lithium was 6.4%. %CV of a control at ~ 0.8 mEq/L lithium was 6.7%.
Assay Sensitivity: 0.03 mEq/L.
Precision Performance: Composite %CV for the blood cell separator system based on 50 samples over 5 days was 8.4% for the low value sample and 5.7% for the high value sample.
Recovery Correlation: R value of 0.993 and an Re value of 0.9866.
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.
Akers Laboratories, Inc. Blood Cell Separator is substantially equivalent to the Vacutainer® Brand Tube for the Determinations Requiring Serum and the Vacutainer® Brand Tube for Hematology and Selective Chemistry Determination, both manufactured and distributed by Becton, Dickinson Company for use in preparing a sample for lithium colorimetric diagnostic testing. Both are pre-amendment devices.
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.
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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
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
0
SEP 1 7 2003
Akers Laboratories, Inc. Blood Cell Separator 510(k) Notification
PREMARKET NOTIFICATION 510(k) Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92"
Ko30815 ני "The assigned 510(k) number is:
| 807.92 (a)(1): Name: | Akers Laboratories, Inc. |
|---|---|
| Address: | 201 Grove Road |
| Thorofare, NJ 08086 | |
| Phone: | (856) 848-8698 |
| FAX: | (856) 848-0269 |
| Contact: | Barbara A. Bagby |
807.92 (a)(2): Device Name - trade name and common name, and classification
| Trade name: | Blood Cell Separator |
|---|---|
| Common name: | Blood Cell/Plasma Separator |
| Classification: | 21 CFR 862.1675 |
| Product Code: JKA |
807.92 (a)(3): Identification of the legally marketed predicate device
"Akers Laboratories, Inc. Blood Cell Separator is substantially equivalent to the Vacutainer® Brand Tube for the Determinations Requiring Serum and the Vacutainer® Brand Tube for Hematology and Selective Chemistry Determination, both manufactured and distributed by Becton, Dickinson Company for use in preparing a sample for lithium colorimetric diagnostic testing. Both are pre-amendment devices."
1
807.92 (a)(4): Device Description
The Blood Cell Separator is intended for use as a sample preparation aid in in vitro lithium colorimetric diagnostic testing systems where a precise, micro-volume sample of serum or plasma is required to be collected from a whole blood specimen.
The Blood Cell Separator consists of two components packaged in a single separator device: the membrane system and a capillary tube. The device is based upon a multiple layer membrane system designed to separate blood cells and serum/plasma. This is achieved through the attraction and capture of blood cells from a whole blood specimen applied to the surface of the membrane system. The residual liquid continues to flow laterally to the tip of the membrane at which time the capillary tube fills vertically to the pipette's fixed, controlled volume and is ready to use.
807.92 (a)(5): Intended Use
The Blood Cell Separator is intended for the use as a sample preparation aid to in vitro Lithium colorimetric diagnostic testing systems where a precise, micro-volume sample of serum or plasma is required to be collected from a whole blood specimen. The liquid produced by the device is dependent upon the sample collected; whole blood collected with an anti-coagulant will produce plasma, and whole blood collected without an anti-coagulant will produce serum.
807.92 (a)(6): Technological Similarities and Differences to Predicate
The following chart exhibits similarities and differences between the Akers Laboratories, Inc. Blood Cell Separator is substantially equivalent to the Vacutainer® Brand Tube for the Determinations Requiring Serum and the Vacutainer® Brand Tube for Hematology and Selective Chemistry Determination, both manufactured and distributed by Becton, Dickinson Company for use in preparing a sample for lithium colorimetric diagnostic testing. Both are pre-amendment devices.
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: 上一篇:
| Characteristic | AKERS
Blood Cell
Separator | PREDICATE
DEVICE
BD Vacutainer®
Brand Tube for the
Determinations
Requiring Serum | PREDICATE
DEVICE
BD Vacutainer®
Brand Tube for
Hematology and
Selective Chemistry
Determinations |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | ------ | Pre-amendment | Pre-amendment |
| Used to collect and separate
blood specimens | Yes | Yes | Yes |
| Separates cells directly from
whole blood sample | Yes | Yes | Yes |
| Produces a liquid fraction | Yes | Yes | Yes |
| Requires centrifugation
technique to separate cells
(pre-treatment) | No | Yes | Yes |
| Separation achieved with
human intervention | No | Yes | Yes |
| Contains an anticoagulant | No | No | Yes |
| Lectin coated membrane
system | Yes | No | No |
| Separated fluid passes
through filter medium | Yes | No | No |
| Yields precise micro-volume
sample | Yes | No | No |
| Sample produced used in
lithium colorimetric analysis | Yes | Yes | Yes |
| Description of Principle | Based upon the
natural clotting
process of whole
blood and the
subsequent
separation of
cellular
components from
serum or plasma
by filtration | Based upon the
natural clotting
process of whole
blood and the
subsequent
separation of
cellular
components from
serum or plasma
by centrifugation | Based upon the
natural clotting
process of whole
blood and the
subsequent
separation of
cellular components
from serum or
plasma by
centrifugation |
The differences in the devices do not raise new issues of safety and effectiveness.
3
807.92 (b)(1): Brief Description of Non-clinical data
Studies were performed to evaluate the analytical performance of the Blood Cell Separator as an aid in preparing a sample for lithium colorimetric diagnostic testing analysis.
The precision standard deviation (SD) ranged from 0.04 to 0.11 mEg/L when samples were assayed in multiple runs over multiple days for both EDTA plasma and serum. Using serum, the percent coefficient of variation (%CV) of a control at ~ 1.5 mEq/L lithum was 6.4% when tested in 50 runs over five days (10 runs per day). Using EDTA plasma, the percent coefficient of variation (%CV) of a control at ~ 0.8 mEq/L lithum was 6.7% when tested in 30 runs over three days (10 runs per day).
The Blood Cell Separator was compared to a routine cell separating technique. Results were listed as total cells per High Powered Field (HPF). The summary data reflected that either method provides a liquid sample containing no blood cells.
The assay sensitivity was 0.03 mEq/L with BD Vacutainer Tube EDTA Plasma Separation and 0.03 mEq/L using the Akers Blood Cell Separation method illustrating equivalent performance.
The daily standard deviation obtained during the five (5) day precision study for the blood cell separator ranged from 0.01 mEq/L to 0.04 mEq/L for the low value sample and 0.03mEq/L to 0.07 mEq/L for the high value sample compared to daily standard deviations for the BD vacutainer system of 0.03 mEq/L to 0.08 mEq/L and 0.03 mEq/L to 0.08 mEq/L respectively for the low and high value samples. The composite percent coefficient of variation (%CV) for the blood cell separator system based on 50 samples over 5 days was 8.4% for the low value sample and 5.7% for the high value sample compared to 9.5% and 6.1%, respectively for the BD vacutainer system. These results illustrated a highly favorable precision performance of the blood cell separator system when compared to the BD vacutainer system.
The recovery correlation yielded an R value of 0.993 and an Re value of 0.9866 illustrating very tight correlation between the two pathways.
4
807.92 (b)(2): Brief Description of Clinical Data
Not applicable, all testing performed via bench by independent laboratory and/or internally.
807.92 (b)(3): Conclusions from Non-clinical and Clinical Testing
The Blood Cell Separator was evaluated for performance characteristics in comprehensive studies. These studies demonstrated that the test is safe and effective for intended use.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines that suggest movement and feathers. The bird is positioned to the right of a semi-circular arrangement of dots, which may represent a halo or a sense of dynamism. The logo has a simple, minimalist design.
Public Health Servic
SEP 1 7 2003
od and Drug Admin 198 Gaither Road Rockville MD 20850
Akers Laboratories, Inc. c/o Mr. Heinz-Joerg Steneberg TUV Rheinland of North America 12 Commerce Road Newtown, CT 06470
Re: K030815
Trade/Device Name: Blood Cell Separator Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: August 29, 2003 Received: September 2, 2003
Dear Mr. Steneberg:
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 either class II (Special Controls) or class III (PMA), 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
510(k) Number (if Known):
2030815 Not known at this time
Device Name: Blood Cell Separator
Indications for Use:
The Blood Cell Separator is intended for the use as a sample preparation aid to in vitro Lithium colorimetric diagnostic testing systems where a precise, micro-volume sample of serum or plasma is required to be collected from a whole blood specimen. The liguid produced by the device is dependent upon the sample collected; whole blood collected with an anti-coagulant will produce plasma, and whole blood collected without an anticoagulant will produce serum.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
(Per 21 CRF 801.109) | | Over-the-Counter Use
(Optional Format 1-2-96) |
|------------------------------------------|-------------|--------------------------------------------------|
| OR | | |
| Dean Cooper | | |
| Division Sign-Off | | |
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K030815Page 36