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.

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.

AI/ML Overview

The Akers Laboratories, Inc. Blood Cell Separator is intended as a sample preparation aid for in vitro lithium colorimetric diagnostic testing. The device separates blood cells from whole blood to produce a precise, micro-volume sample of serum or plasma without the need for centrifugation. The acceptance criteria and performance were assessed through non-clinical studies comparing the device to predicate devices (BD Vacutainer® Brand Tubes).

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit from Predicate Equivalence)	Reported Device Performance (Akers Blood Cell Separator)
Accuracy / Equivalent Lithium Measurement Performance: Assays should yield lithium concentration results comparable to predicate devices.	Precision (Lithium Concentration):- Serum: Control at ~1.5 mEq/L lithium had a 6.4% CV over 50 runs/5 days.- EDTA Plasma: Control at ~0.8 mEq/L lithium had a 6.7% CV over 30 runs/3 days.- Daily SD for low value sample: 0.01 to 0.04 mEq/L (compared to BD Vacutainer 0.03 to 0.08 mEq/L).- Daily SD for high value sample: 0.03 to 0.07 mEq/L (compared to BD Vacutainer 0.03 to 0.08 mEq/L).- Composite %CV over 50 samples/5 days: - Low value: 8.4% (compared to BD Vacutainer 9.5%). - High value: 5.7% (compared to BD Vacutainer 6.1%).Recovery Correlation: R value of 0.993, Re value of 0.9866 (between Akers and BD Vacutainer methods).Assay Sensitivity: 0.03 mEq/L (equivalent to BD Vacutainer Tube EDTA Plasma Separation).
Efficient Cell Separation: The resultant liquid sample should be free of blood cells.	Cell Count: Liquid sample contained "no blood cells" based on comparison to a routine cell separating technique (results listed as total cells per High Powered Field (HPF)).
Functional Equivalence: Ability to provide a sample suitable for lithium colorimetric analysis.	Yes, the device provides a liquid fraction (serum or plasma) used in lithium colorimetric analysis.

2. Sample size used for the test set and the data provenance:

Sample Size:
- Precision Study (Serum): 50 runs over 5 days (10 runs per day) for a control at ~1.5 mEq/L lithium.
- Precision Study (EDTA Plasma): 30 runs over 3 days (10 runs per day) for a control at ~0.8 mEq/L lithium.
- Overall Precision Study: 50 samples over 5 days for both low and high value lithium samples (implicitly comparing to predicate).
- Cell Separation Comparison: Number of samples not explicitly stated beyond "summary data."
- Assay Sensitivity: Not explicitly stated, but implies comparison data.
- Recovery Correlation: Not explicitly stated.
Data Provenance: The studies were non-clinical, performed "via bench by independent laboratory and/or internally." The document does not specify the country of origin but implies laboratory-controlled experiments. The studies were prospective in nature, designed to test the device's performance attributes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. Given that the studies were non-clinical (bench testing), there were likely no "experts" in the clinical sense establishing ground truth. The ground truth for lithium concentration was established by the analytical reference methods or control values used in the testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable as the studies were non-clinical, analytical performance evaluations, not clinical studies involving human observers or subjective assessments that would require adjudication.

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:

No, an MRMC comparative effectiveness study was not done. This device is a sample preparation aid, not an AI-powered diagnostic imaging tool that would involve human readers or AI assistance in interpretation. The studies focused on the analytical performance of the device itself.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, the studies conducted were standalone performance evaluations of the device. The device itself is an automated sample preparation tool, and its performance was assessed directly through analytical measurements of the prepared samples. There is no "human-in-the-loop" component in the device's function or in the evaluation mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the performance studies was based on:

Reference Standard Values: For lithium concentration, established control values or reference methods were used to determine precision and accuracy (implied by comparison studies).
Analytical Measurement: Quantitative measurements of lithium concentration and cell counts (e.g., cells per HPF) served as the objective ground truth against which the device's performance was measured.

8. The sample size for the training set:

The concept of a "training set" is not applicable to this device. It is a physical medical device for sample preparation, not an AI/machine learning algorithm requiring a training dataset.

9. How the ground truth for the training set was established:

As the concept of a training set is not applicable, this question is not relevant to the provided information.

Summary

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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 RoadThorofare, 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 862.1675Product 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."

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807.92 (a)(4): Device Description

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	AKERSBlood CellSeparator	PREDICATEDEVICEBD Vacutainer®Brand Tube for theDeterminationsRequiring Serum	PREDICATEDEVICEBD Vacutainer®Brand Tube forHematology andSelective ChemistryDeterminations
510(k) Number	------	Pre-amendment	Pre-amendment
Used to collect and separateblood specimens	Yes	Yes	Yes
Separates cells directly fromwhole blood sample	Yes	Yes	Yes
Produces a liquid fraction	Yes	Yes	Yes
Requires centrifugationtechnique to separate cells(pre-treatment)	No	Yes	Yes
Separation achieved withhuman intervention	No	Yes	Yes
Contains an anticoagulant	No	No	Yes
Lectin coated membranesystem	Yes	No	No
Separated fluid passesthrough filter medium	Yes	No	No
Yields precise micro-volumesample	Yes	No	No
Sample produced used inlithium colorimetric analysis	Yes	Yes	Yes
Description of Principle	Based upon thenatural clottingprocess of wholeblood and thesubsequentseparation ofcellularcomponents fromserum or plasmaby filtration	Based upon thenatural clottingprocess of wholeblood and thesubsequentseparation ofcellularcomponents fromserum or plasmaby centrifugation	Based upon thenatural clottingprocess of wholeblood and thesubsequentseparation ofcellular componentsfrom serum orplasma bycentrifugation

The differences in the devices do not raise new issues of safety and effectiveness.

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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.

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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.

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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

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510(k) Number (if Known):

2030815 Not known at this time

Device Name: Blood Cell Separator

Indications for Use:

(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

Regulation Number and Section

§ 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.