(31 days)
The Linearity FD Unsaturated Iron Binding Capacity is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for unsaturated iron binding capacity.
Linearity FD Unsaturated Iron Binding Capacity is for In Vitro Diagnostic use only.
Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity product is an in-vitro diagnostic device consisting of five levels of freeze dried, linearity/QC material, containing additives in human serum. There are five levels labeled A,B,C,D and E which contain 1ml for each level.
The provided document is a 510(k) premarket notification decision letter from the FDA for the Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain a detailed study proving the device meets acceptance criteria in the way typically expected for a diagnostic or AI-driven medical device.
The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K130157 Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set) based on similar intended use and technical characteristics. It mentions performance data related to stability and value assignment, but not clinical performance with respect to patient outcomes or comparison against a diagnostic gold standard in a traditional clinical study.
Here's an attempt to extract and organize the information based on your request, with significant caveats that much of the requested information (especially for AI/ML device performance) is not present in this type of regulatory submission for a quality control material:
Device Name: Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity
Device Type: Assayed Quality Control Material for Unsaturated Iron Binding Capacity (UIBC)
Intended Use: To simulate human patient samples for use in determining linearity, calibration verification, and the verification of reportable range for unsaturated iron binding capacity. For In Vitro Diagnostic use only.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this device (a quality control material), the "acceptance criteria" and "device performance" are primarily related to its stability and its ability to provide target values within a specified range, demonstrating linearity. This is not a diagnostic device with performance metrics like sensitivity, specificity, or AUC.
| Acceptance Criteria Category | Specific Criteria/Metric | Reported Device Performance/Status |
|---|---|---|
| Shelf Life Stability | Not explicitly stated as a numerical criterion in % difference, but implied "within acceptance criteria" for comparison of real-time vials to Day0 values. | - Accelerated Stability: Met acceptance criteria to support 24 months shelf life. - Real-Time Stability: Ongoing studies, but "product is determined to meet its predicted shelf life if the % difference of the real-time mean values compared to the Day0 mean value is within the acceptance criteria." (indicating current data supports predicted shelf life) Claimed Shelf Life: 24 months, when stored unopened at 2-8°C. |
| Reconstituted Vial Stability | Not explicitly stated as a numerical criterion, but implied "within acceptance criteria." | - Accelerated + Real-Time Stability: Met acceptance criteria. Claimed Reconstituted Vial Stability: 30 days when stored tightly capped at 2-8°C. |
| Value Assignment / Linearity | Target ranges for each of the five levels (calculated as +/-15% of the target mean values). | Individual analyte values for Level A through Level E were measured multiple times on a Hitachi P-Modular analyzer. The mean value of UIBC was used to establish target values. Reported Target Values and Ranges (µg/dL): - Level A: Target 75.7 (Range 64.4-87.1) - Level B: Target 185.5 (Range 157.7-213.4) - Level C: Target 297.3 (Range 252.7-341.9) - Level D: Target 403.7 (Range 343.2-464.3) - Level E: Target 525.1 (Range 446.3-603.8) |
| AMR (Analytical Measuring Range) | Not explicitly stated as an "acceptance criterion" but reported as a characteristic. | Unsaturated Iron Binding Capacity: 10-500 µg/dL. This range encompasses the target values of the linearity levels. |
Information Not Applicable or Not Provided in this Document:
The following points are typically relevant for AI/ML-driven diagnostic devices or clinical studies, which are not the subject of this 510(k) for a quality control material. Therefore, the requested information is either not applicable or not provided in this submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for a QC material in this context. The "test sets" would refer to analytical samples used for stability and value assignment, not patient data for diagnostic evaluation. The document mentions "samples are taken at four different time points" for real-time stability and "each analyte was measured multiple times" for value assignment.
- Data Provenance: The studies were conducted internally by Aalto Scientific, Ltd. (Carlsbad, CA, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. "Ground truth" in the clinical diagnostic sense is not established for a quality control material. The "truth" here relates to the analytical value determined by the reference method (Hitachi P-Modular) and the stability performance compared to a baseline.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process is described for this type of analytical validation.
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
- Not applicable. This is not an AI/ML device or a diagnostic device requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance of this quality control material is its analytical value as determined by a reference laboratory instrument (Hitachi P-Modular) and its demonstrated stability over time according to pre-defined internal acceptance criteria. It is an analytical "truth," not a clinical "ground truth."
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set." The measurements for stability and value assignment are based on multiple replicates as described in the methodology.
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 8, 2014
AALTO SCIENTIFIC LTD. ROBERT BURDA REGULATORY AFFAIRS MANAGER 1959 KELLOGG AVE. CARLSBAD CA 92008
Re: K143026
Trade/Device Name: Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Code: JJX Dated: November 21, 2014 Received: November 21, 2014
Dear Mr. Robert Burda:
This letter corrects our substantially equivalent letter of November 21, 2014. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
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Page 2 – Mr. Burda
CFR Part 807); labeling Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Katherine Serrano -S
For : Courtney H. Lias, Ph.D.
Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143026
Device Name
Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity
Indications for Use (Describe)
The Linearity FD Unsaturated Iron Binding Capacity is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for unsaturated iron binding capacity.
Linearity FD Unsaturated Iron Binding Capacity is for In Vitro Diagnostic use only.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
A. Submitter
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 Fax: (760) 431-6942
Contact Person
Robert Burda Regulatory Affairs Manager Telephone: (760) 431-7922 ext. 134 Email: rburda@aaltoscientific.com
Date of Summary Preparation
November 19, 2014
B. Device Identification
| Product Trade Name: | Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity |
|---|---|
| Common Name: | Quality Control Material (Assayed and Unassayed) |
| Review Panel: | Clinical Chemistry and Clinical Toxicology Devices |
| Device Classification: | Class I, Reserved |
| Product Code: | JJX |
| Regulation Number: | 21CFR862.1660 |
C. Device to Which Substantial Equivalence is Claimed
K130157 Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set
D. Intended Use
The Linearity FD Unsaturated Iron Binding Capacity is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration verification, and the verification of reportable range for unsaturated iron binding capacity.
Linearity FD Unsaturated Iron Binding Capacity is for In Vitro Diagnostic use only.
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| Characteristics | Audit® MicroControls™Linearity FD Unsaturated IronBinding Capacity(New Device) | Audit® MicroCV™ Beta-Hydroxybutyric AcidLinearity Set(Predicate Device, K130157) |
|---|---|---|
| Intended Use | The Linearity FD UnsaturatedIron Binding Capacity is anassayed quality control materialintended to simulate humanpatient samples for use indetermining linearity, calibrationverification, and the verificationof reportable range forunsaturated iron bindingcapacity.Linearity FD Unsaturated IronBinding Capacity is for In VitroDiagnostic use only. | The Audit® MicroCV™ Beta-Hydroxybutyric AcidLinearity Set is an assayedquality control materialconsisting of five levels ofhuman based serum. Eachlevel contains Beta-Hydroxybutyric Acid. Thesefive levels demonstrate alinear relationship to eachother for Beta-Hydroxybutyric Acid. It isintended to simulate humanpatient serum samples forpurpose of determininglinearity, calibrationverification and verificationof reportable range for Beta-Hydroxybutyric Acid.The product is intended foruse with quantitative assayson the indicated analyzerprovided in the labeling andmay be used as quality controlmaterial for Beta-Hydroxybutyric Acid. Whenused for quality controlpurposes, it is recommendedthat each laboratory establishits own means and acceptableranges and use the valuesprovided only as guides. TheAudit® MicroCV™ Beta-Hydroxybutyric AcidLinearity Set should not beused for calibration orstandardization of the Beta-Hydroxybutyric Acid assay. |
E. Technical Characteristics Compared to Predicate Device
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| Hydroxybutyric AcidLinearity Set is “For In VitroDiagnostic Use Only”. | ||
|---|---|---|
| Number of Levelsper Set | 5 | 5 |
| Contents | 5x1ml | 5x1ml |
| Matrix | Human Based Serum | Human Based Serum |
| Type of Analytes | Clinical Chemistry | Clinical Chemistry |
| Form | Freeze Dried | Liquid |
| Storage | 2-8°C | 2-8°C |
| Open Vial/ReconStability | 30 days at 2-8°C | 40 days at 2-8°C |
| Sterile | No | No |
| Analytes | Unsaturated Iron BindingCapacity | Beta-hydroxybutyric acid |
| Number ofAnalytes per Vial | 1 | 1 |
F. Device Description
Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity product is an in-vitro diagnostic device consisting of five levels of freeze dried, linearity/QC material, containing additives in human serum. There are five levels labeled A,B,C,D and E which contain 1ml for each level.
Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.
G. Value Assignment/Linearity
Each analyte value assignment for Level A through Level E is performed on Hitachi P-Modular by using the corresponding reagent. Each analyte was measured multiple times. The unsaturated iron binding capacity (UIBC) was measured and the mean value of the iron binding capacity was used to establish target iron binding capacity values at each level.
AMR
Unsaturated Iron Binding Capacity: 10-500 µg/dL
H. Summary of Performance Data
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Stability studies have been performed to determine the reconstituted vial stability and shelf life for the Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity.
Shelf Life-Accelerated Stability
Accelerated stability studies were conducted to establish the shelf life stability claims. All supporting data is retained on file at Aalto Scientific, Ltd. Acceptance criteria were met to support the product claims as follows.
Shelf Life: 24 months, when stored unopened at 2-8°C.
Shelf Life-Real Time Stability
Vials from two lots of finished product are stored at 2-8℃ (real time vials) and -80℃ (Dayl) vials). Samples are taken at four different time points. The analyte values from the real time vials are compared to the Day0 vials (both tested in duplicate). The product is determined to meet its predicted shelf life if the % difference of the real time mean values compared to the Day) mean value is within the acceptance criteria. All supporting data is retained on file at Aalto Scientific, Ltd.
Note: Real time studies are ongoing to support the shelf life of this product.
Reconstituted Vial-Accelerated Stability+Real Time Stability
Real time stability studies were conducted at the end of accelerated stability studies to establish the reconstituted vial stability claims. All supporting data is retained on file at Aalto Scientific, Ltd. Acceptance criteria were met to support the product claims as follows.
Reconstituted Vial Stability: Once a vial has been opened and reconstituted, the product will be stable for 30 days when stored tightly capped at 2-8° C.
I. Expected Values/Value Assignment
Value assignment of Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity have been performed to determine the expected values of the unsaturated iron binding capacity. Each unsaturated iron binding capacity value assignment for Level A through Level E is performed on Hitachi P-Modular by using the corresponding reagent. The unsaturated iron binding capacity was measured multiple times and the mean value of unsaturated iron binding capacity was used to establish target values at each level. The target ranges were calculated as +/-15% of the target mean values.
All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
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| Level A | Level B | Level C | Level D | Level E | |||||
|---|---|---|---|---|---|---|---|---|---|
| Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange |
| 75.7 | 64.4-87.1 | 185.5 | 157.7-213.4 | 297.3 | 252.7-341.9 | 403.7 | 343.2-464.3 | 525.1 | 446.3-603.8 |
J. Traceability
Materials are obtained from internally qualified vendors and are subject to an internal quality control process. Raw material information is retained on file at Aalto Scientific, Ltd.
K. Conclusions
Based upon the purpose of the device, the descriptions and labeling of the predicate device, the safety and efficacy, and the stability data generated, the product is substantially equivalent to the predicate device.
§ 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.