AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5

K082714 · Aalto Scientific, Ltd. · JJY · Nov 19, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082714
• Device Name: AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Therapeutic Drug (TDM) Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived Therapeutic Drug (TDM) testing methods as identified in the package insert.

Device Story

Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set is a lyophilized, five-level QC material containing 14 therapeutic drug analytes in a human and bovine serum albumin matrix. Levels A-E are prepared via linear dilution; Level A represents the lower limit and Level E the upper limit of instrument ranges. Used in clinical laboratories to verify/validate analytical measurement ranges, perform CLIA-directed calibration verification, and monitor precision/detect systematic analytical deviations. Healthcare providers reconstitute the material and process it through TDM testing methods on clinical analyzers. Output is compared against expected linear values to confirm instrument performance and ensure accurate patient sample testing. Benefits include improved reliability of therapeutic drug monitoring and compliance with CLIA-88 guidelines.

Clinical Evidence

No clinical data. Performance is supported by bench testing, including stability studies confirming 5-day reconstituted stability at 2-8°C and a 2-year shelf life at 2-8°C.

Technological Characteristics

Lyophilized, five-level serum albumin-based matrix (human and bovine). Contains 14 therapeutic drug analytes. Preserved with sodium azide. Storage at 2-8°C. Reconstituted stability of 5 days at 2-8°C. Traceability to USP standard references.

Indications for Use

Indicated for use as a five-level quality control material in human and bovine serum albumin matrix to verify/validate analytical measurement range, perform calibration verification, and serve as unassayed/assayed QC for 14 therapeutic drugs: Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Methotrexate, Phenobarbital, Phenytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valproic Acid, and Vancomycin. For professional use in clinical laboratories.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Audit™ MicroCV™ General Chemistry Linearity Set (K042318)

Submission Summary (Full Text)

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Kord2714

Image /page/0/Picture/1 description: The image shows a logo for Aalto Scientific, Ltd. The logo consists of a triangular shape made up of many smaller triangles. The text "Aalto Scientific, Ltd" is written below the triangular shape.

NOV 1 9 2008

510(k) Summary

# A. Submitter

Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: [phone] Fax: [phone]

#### B. Contact Person

Brandon J Perez Telephone: [phone] Ext. 120 E-mail: [e-mail]

### C. Date of Summary Preparation

September 13, 2008

# D. Device Identification

Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Product Trade Name: Set Therapeutic Drug (TDM) Linearity Common Name: Assay QC Material Classification Name: Device Classification: Class I 21 CFR 862.1660 Regulation Number: 75 Panel: Product Code: JJY

#### E. Device to Which Substantial Equivalence is Claimed

Audit™ MicroCV™ General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, CA K042318

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Image /page/1/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo features a triangular shape at the top, which appears to be composed of many small dots or pixels. Below the triangular shape, the text "Aalto Scientific, Ltd" is written in a simple, sans-serif font. The text is aligned centrally beneath the triangular shape.

# F. Description of the Device

The Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set is a human based, lyophilized, five level set of QC material, with each level containing 14 analytes. It is used to confirm the proper calibration, linear operating range, and reportable range of Therapeutic Drug (TDM) methods for the analytes listed. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B -- D are related by linear dilution of Level A and Level E.

# G. Statement of Intended Use

The Therapeutic Drug (TDM) Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived Therapeutic Drug (TDM) testing methods as identified in the package insert.

# I. Summary of Performance Data

Stability studies have been performed to determine the reconstituted stability and shelf life for the Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set. All supporting data is rctained on file at Aalto Scientific, Ltd. Product claims are as follows:

Reconstituted Stability: Once a vial has been reconstituted, all analytes will be stable for 5 days when stored tightly capped at 2 - 8° C.

Shelf Life: Two years, when stored unopened at 2 - 8° C. Note: Real time studies are ongoing to support the shelf life of this product.

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Image /page/2/Picture/0 description: The image shows the logo for Aalto Scientific, Ltd. The logo features a stylized triangular shape above the company name. The triangular shape is composed of many smaller shapes, creating a textured effect. The text "Aalto Scientific, Ltd." is written in a simple, sans-serif font.

# H. Technical Characteristics Compared to Predicate Device

| Characteristics | Audit™ MicroCV™ Therapeutic Drug<br>(TDM) Linearity Set<br>(New Device) | Audit™ MicroCV™ General Chemistry<br>Linearity Set<br>(K042318) |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Audit™ MicroCV™ Therapeutic Drug<br>(TDM) Linearity Set is assayed quality<br>control material consisting of human and<br>animal based serum albumin. It is<br>intended to simulate human patient<br>serum samples for the purpose of<br>monitoring the precision and to detect<br>systematic analytical deviations of<br>laboratory testing procedures. This<br>product may also be used as unassayed<br>quality control material for these same<br>analytes and may be used for proficiency<br>testing in interlaboratory surveys. In<br>addition, this product may also be used<br>to perform CLIA directed calibration<br>verification for these same analytes with<br>similar reagents on similar<br>instrumentation in accordance with<br>current CLIA-88 guidelines and<br>regulations. | Audit™ MicroCV™ General Chemistry<br>Linearity Set is assayed quality control<br>material consisting of human based<br>serum. It is intended to simulate human<br>patient serum samples for the purpose of<br>monitoring the precision and to detect<br>systematic analytical deviations of<br>laboratory testing procedures. This<br>product may also be used as unassayed<br>quality control material for these same<br>analytes and may be used for proficiency<br>testing in interlaboratory surveys. In<br>addition, this product may also be used to<br>perform CLIA directed calibration<br>verification for these same analytes with<br>similar reagents on similar<br>instrumentation in accordance with<br>current CLIA-88 guidelines and<br>regulations. |
| Number of<br>Analytes per vial | 14 | 30 |
| Number of levels<br>per set | 5 | 5 |
| Contents | 5 x 5 mL | 5 x 5 mL |
| Matrix | Human and animal based serum albumin | Human Based Serum |
| Type of Analytes | Therapeutic Drug | General Chemistry |
| Form | Lyophilized | Lyophilized |
| Stabilizers | None | None |
| Preservatives | Sodium azide | Sorbitol<br>Sodium azide |
| Storage | 2 to 8° C<br>Until expiration date | 2 to 8° C<br>Until expiration date |
| Reconstituted<br>Stability | 5 days at 2 to 8° C | 7 days at 2 to 8° C except for enzymes<br>and bilirubin, which are 48 hours |

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Image /page/3/Picture/0 description: The image shows the logo for Aalto Scientific, Ltd. The logo features a stylized triangular shape at the top, which appears to be composed of smaller geometric elements. Below the triangular shape, the text "Aalto Scientific, Ltd." is written in a simple, sans-serif font.

# J. Conclusions

Based upon the purpose of the device, the descriptions and labeling of the predicate device, the safety and efficacy, and the stability data gencrated, the product is substantially equivalent to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Aalto Scientific Ltd. c/o Mr. Brandon J. Perez Research and Development Scientist 1959 Kellogg Avenue Carlsbad, CA 92008

NOV 1 9 2008

Re: k082714

Trade Name: Audit MicroCV Therapeutic Drug (TDM) Lincarity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJY Dated: September 16, 2008 Received: September 18, 2008

Dear Mr. Perez:

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. Iisting 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 (OS) regulation (21 CFR Part 820).

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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). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): anknown KORLTIT

Device Name: Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set

Indications For Use:

The Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set consists of five levels in Human and Bovine serum albumin matrix. Each level contains the following analytes: Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Methotrexate, Phenobarbital, Phenytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valoroic Acid and Vancomycin. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.

This product may be used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations.

In addition, Level A – E of this product may be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

DYLAN DUGGAN

of In Viro Diagnostic Device and Sale