(63 days)
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.
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.
The provided text is a 510(k) Summary for a Quality Control Material (QCM), specifically the Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set. Devices of this type are not typically evaluated with the extensive criteria common for diagnostic AI algorithms (e.g., performance metrics like sensitivity, specificity, or ROC curves against a ground truth from experts). Instead, the assessment focuses on their characteristics matching their intended use as QCMs, primarily stability and linearity, and their substantial equivalence to a predicate device.
Therefore, many of the requested categories in your prompt are not applicable or directly derivable from this type of regulatory submission. I will address the relevant information that can be extracted.
Not Applicable (N/A) Categories for this type of device and submission:
- Sample size used for the test set and the data provenance: Not applicable. Performance for QCMs is typically demonstrated through characteristics like stability and linearity, not by processing a "test set" of patient data in the way an AI algorithm would.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI algorithms involves expert interpretation; for QCMs, it's about analytical performance.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical control material, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a QCM, "ground truth" relates to the expected values and behavior of the reference material itself, established through analytical methods and manufacturing processes, not expert medical opinion on a patient.
- The sample size for the training set: Not applicable, as this is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
Relevant Information and Acceptance Criteria for the Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set:
The device's performance is primarily demonstrated by its stability and its ability to establish a linear relationship for the specified analytes. Its acceptance criteria are implicitly tied to maintaining these characteristics over time. The "study" mentioned refers to internal stability studies.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit) | Reported Device Performance/Characteristics |
|---|---|---|
| Intended Use Fulfillment | The device should "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." It should also allow for "proficiency testing" and "CLIA directed calibration verification." | - Consists of a human based, lyophilized, five-level set of QC material.- Each level contains 14 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." |
| Reconstituted Stability | Maintain analyte stability for a specified period after reconstitution when stored under defined conditions. | 5 days when stored tightly capped at 2 - 8° C. |
| Shelf Life | Maintain stability for a specified period when stored unopened under defined conditions. | Two years when stored unopened at 2 - 8° C. (Note: Real-time studies are ongoing to support this claim). |
| Linearity | The five levels (A-E) should demonstrate a linear relationship for the specified analytes. | Levels A-E "demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments." Levels B-D are related by linear dilution of Level A and Level E. |
2. Data Provenance for Performance Evaluation:
- Test Set (for performance demonstration of stability and linearity): The document states "All supporting data is retained on file at Aalto Scientific, Ltd." This implies the data originates from internal studies conducted by the manufacturer.
- Country of Origin: United States (Aalto Scientific, Ltd. is located in Carlsbad, CA).
- Retrospective or Prospective: Stability studies are typically prospective, meaning the product is manufactured and then monitored over time according to a predefined protocol. Linearity verification would also be a prospective test using the manufactured material.
3. Study Proving Acceptance Criteria:
The document explicitly mentions:
- "Stability studies have been performed to determine the reconstituted stability and shelf life for the Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set."
- These studies prove the device meets the Reconstituted Stability and Shelf Life acceptance criteria.
- The "linear relationship" of the five levels is a fundamental characteristic of the device's design and is presumably verified during development and quality control testing, fulfilling the Linearity criterion.
6. Standalone Performance:
Yes, the performance claims (stability, linearity for TDM methods) are for the algorithm/device only, in the sense that the physical control material itself has these properties, independent of human interpretation or assistance in its function as a control. It is a standalone diagnostic reagent used to evaluate other analytical systems.
9. How the Ground Truth for the Training Set (or rather, the Reference Values for the QCM) was Established:
While there is no "training set" in the AI sense, the concentrations and intended linear relationship of the analytes within the QCM are established during its manufacturing process. This involves:
- Formulation and Dilution: Levels B-D are created by linear dilution of Level A and Level E. This precise formulation establishes the expected "linear ground truth" for calibration verification.
- Master Lot Testing/Value Assignment: For quality control materials, reference methods and/or highly characterized instruments are used to assign target values to each analyte in each level. This process establishes the expected 'ground truth' values against which user instruments can be calibrated and verified. The document does not detail this specific process but it is standard for QCM manufacturing.
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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: (760) 431-7922 Fax: (760) 431-6824
B. Contact Person
Brandon J Perez Telephone: (760) 431-7922 Ext. 120 E-mail: bperez@aaltoscientific.com
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(TDM) Linearity Set(New Device) | Audit™ MicroCV™ General ChemistryLinearity Set(K042318) |
|---|---|---|
| Intended Use | Audit™ MicroCV™ Therapeutic Drug(TDM) Linearity Set is assayed qualitycontrol material consisting of human andanimal based serum albumin. It isintended to simulate human patientserum samples for the purpose ofmonitoring the precision and to detectsystematic analytical deviations oflaboratory testing procedures. Thisproduct may also be used as unassayedquality control material for these sameanalytes and may be used for proficiencytesting in interlaboratory surveys. Inaddition, this product may also be usedto perform CLIA directed calibrationverification for these same analytes withsimilar reagents on similarinstrumentation in accordance withcurrent CLIA-88 guidelines andregulations. | Audit™ MicroCV™ General ChemistryLinearity Set is assayed quality controlmaterial consisting of human basedserum. It is intended to simulate humanpatient serum samples for the purpose ofmonitoring the precision and to detectsystematic analytical deviations oflaboratory testing procedures. Thisproduct may also be used as unassayedquality control material for these sameanalytes and may be used for proficiencytesting in interlaboratory surveys. Inaddition, this product may also be used toperform CLIA directed calibrationverification for these same analytes withsimilar reagents on similarinstrumentation in accordance withcurrent CLIA-88 guidelines andregulations. |
| Number ofAnalytes per vial | 14 | 30 |
| Number of levelsper 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 | SorbitolSodium azide |
| Storage | 2 to 8° CUntil expiration date | 2 to 8° CUntil expiration date |
| ReconstitutedStability | 5 days at 2 to 8° C | 7 days at 2 to 8° C except for enzymesand 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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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
§ 862.1660 Quality control material (assayed and unassayed).
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.