AKERS LABORATORIES INC. BLOOD CELL SEPARATOR

K030815 · Akers Laboratories, Inc. · JKA · Sep 17, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030815
• Device Name: AKERS LABORATORIES INC. BLOOD CELL SEPARATOR
• Applicant: Akers Laboratories, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Sep 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Blood Cell Separator is intended for 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 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.

Device Story

The Blood Cell Separator is a manual sample preparation device used to collect and separate serum or plasma from whole blood specimens for lithium colorimetric diagnostic testing. The device consists of a multi-layer membrane system and a capillary tube. Whole blood is applied to the membrane surface; the membrane captures blood cells while the residual liquid flows laterally to the tip of the membrane. The capillary tube then fills via capillary action to a fixed, controlled volume. The device eliminates the need for centrifugation and manual intervention during the separation process. It is intended for use in clinical settings where precise micro-volume samples are required. The resulting serum or plasma is then used by healthcare providers for diagnostic analysis, facilitating patient lithium level monitoring.

Clinical Evidence

Bench testing only. Precision study (n=200) compared lithium measurement results between the subject device and BD Vacutainer system; composite %CV was 8.4% (low) and 5.7% (high) for the subject device versus 9.5% and 6.1% for the predicate. Method comparison study (n=25) using spiked whole blood samples (0.1–2.5 mEq/L) yielded R=0.993 and R²=0.9866 compared to centrifugation. Analytical sensitivity was 0.03 mEq/L for both methods.

Technological Characteristics

Consists of a lectin-coated multi-layer membrane system and a capillary tube. Separation principle: filtration via lectin-coated membrane. Energy source: none (passive wicking). Form factor: membrane system and capillary tube assembly. No software or electronic components.

Indications for Use

Indicated for use as a sample preparation aid for in vitro lithium colorimetric diagnostic testing. Collects precise micro-volumes of serum or plasma from whole blood specimens for patients requiring lithium level monitoring.

Regulatory Classification

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.

Predicate Devices

• Vacutainer® Brand Tube for the Determinations Requiring Serum (Pre-amendment)
• Vacutainer® Brand Tube for Hematology and Selective Chemistry Determination (Pre-amendment)

Submission Summary (Full Text)

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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 Road<br>Thorofare, NJ 08086 |
| Phone: | [phone] |
| FAX: | [phone] |
| 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<br>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."

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## 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<br>Blood Cell<br>Separator | PREDICATE<br>DEVICE<br>BD Vacutainer®<br>Brand Tube for the<br>Determinations<br>Requiring Serum | PREDICATE<br>DEVICE<br>BD Vacutainer®<br>Brand Tube for<br>Hematology and<br>Selective Chemistry<br>Determinations |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | ------ | Pre-amendment | Pre-amendment |
| Used to collect and separate<br>blood specimens | Yes | Yes | Yes |
| Separates cells directly from<br>whole blood sample | Yes | Yes | Yes |
| Produces a liquid fraction | Yes | Yes | Yes |
| Requires centrifugation<br>technique to separate cells<br>(pre-treatment) | No | Yes | Yes |
| Separation achieved with<br>human intervention | No | Yes | Yes |
| Contains an anticoagulant | No | No | Yes |
| Lectin coated membrane<br>system | Yes | No | No |
| Separated fluid passes<br>through filter medium | Yes | No | No |
| Yields precise micro-volume<br>sample | Yes | No | No |
| Sample produced used in<br>lithium colorimetric analysis | Yes | Yes | Yes |
| Description of Principle | Based upon the<br>natural clotting<br>process of whole<br>blood and the<br>subsequent<br>separation of<br>cellular<br>components from<br>serum or plasma<br>by filtration | Based upon the<br>natural clotting<br>process of whole<br>blood and the<br>subsequent<br>separation of<br>cellular<br>components from<br>serum or plasma<br>by centrifugation | Based upon the<br>natural clotting<br>process of whole<br>blood and the<br>subsequent<br>separation of<br>cellular components<br>from serum or<br>plasma by<br>centrifugation |

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 [phone]. 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 [phone] or [phone] 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:

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CRF 801.109) | <div></div> | Over-the-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|-------------|--------------------------------------------------|
| OR | | |
| <i>Dean Cooper</i> | | |
| Division Sign-Off | | |

Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K030815Page 36