(30 days)
The Linearity FD Tumor Markers II 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 the following analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigen-total (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), Carbonic Anhydrase 27-29 (CA27-29)(BR), free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3).
The Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.
The Audit® MicroControls™ Linearity FD Tumor Markers II product is an in-vitro diagnostic device consisting of two sets of five levels of liquid, linearity/QC material. Set 1 contains the analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigentotal (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), and Carbonic Anhydrase 27-29 (CA27-29) (BR) and additives in human serum. Set 2 contains the analytes: free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3) and additives in human serum and bovine serum. For each set there are five levels labeled A, B, C, D and E. Both sets 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.
This document is a 510(k) summary for the Audit® MicroControls™ Linearity FD Tumor Markers II, a quality control material. It describes the device's intended use and compares it to a predicate device (K082717 Audit® MicroCV™ Tumor Markers Linearity Set). The primary focus of the performance data section is on stability studies and value assignment, not diagnostic accuracy or comparative effectiveness with human readers.
Here's an analysis of the provided information concerning acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document outlines acceptance criteria for stability (shelf life and reconstituted vial stability) and expected value ranges for various analytes.
Acceptance Criteria and Reported Device Performance
| Feature/Analyte | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf Life | Not explicitly stated as a numerical criterion, but implies meeting product claims. | 2 years, when stored unopened at 2-8°C. (Supported by accelerated stability studies). |
| Reconstituted Stability | Not explicitly stated as a numerical criterion, but implies meeting product claims. | 14 days when stored tightly capped at 2-8°C. (Supported by accelerated stability + real-time stability studies). |
| Expected Values (General) | Target ranges calculated as +/-20% of the target mean values. | All analytes (AFP, CEA, PSA, CA125, CA27-29 (BR), CA15-3, CA19-9, fPSA) were assigned target values and corresponding target ranges (e.g., AFP: 8.2 ng/ml target, 6.5-9.8 ng/ml range). Specific values are provided in the tables within the document. |
| Real-time Stability (% Difference) | % difference of real-time mean values compared to Day0 mean value is within "the acceptance criteria" (specific numerical criterion not provided). | Studies are ongoing. Suggests initial results met internal acceptance criteria for the time points tested. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify a "test set" in the context of diagnostic accuracy. The performance data focuses on stability and value assignment of the quality control material itself.
- For accelerated stability, it mentions "All supporting data is retained on file at Aalto Scientific, Ltd." but doesn't quantify the number of samples or lots.
- For real-time stability, it states "Vials from two lots of finished product are stored at 2-8℃ (real time vials) and -80℃ (Dayl vials). Samples are taken at two different time points."
- For value assignment, it mentions each analyte was "measured multiple times" on specific instruments (Siemens Advia Centaur and Abbott Architect i1000SR).
- Data Provenance: The studies were conducted by Aalto Scientific, Ltd., located in Carlsbad, CA, USA. The data would therefore be considered prospective as it relates to the manufacturing and testing of their product. The matrix for the product uses "Human Based Serum and bovine based serum," but this refers to the components of the QC material itself, not patient samples.
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)
This section is not applicable to this document. The device is a quality control material, not a diagnostic device that requires expert interpretation of results for ground truth. The "ground truth" for the QC material is its assigned target values based on measurements by calibrated instruments and established reference methods (implied through the use of specific analyzers and reagents).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. There is no "test set" in the context of diagnostic performance requiring 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
This section is not applicable. The device is a quality control material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a quality control material, not an algorithm. What might be considered "standalone performance" for this device is its ability to maintain its assigned values over time (stability) and the accuracy of its initial value assignments, which are demonstrated through the described studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this quality control material, the "ground truth" is established through:
- Reference Instrument Measurement: Analytes were measured multiple times on specific, high-precision clinical chemistry analyzers (Siemens Advia Centaur and Abbott Architect i1000SR) using corresponding reagents. These instruments themselves are calibrated against established reference standards.
- Mean Value Calculation: The mean value of multiple measurements for each analyte at each level was used to establish the "target concentration value."
8. The sample size for the training set
This section is not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the conventional sense. The development of the QC material involves formulation and initial testing, but not machine learning training.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2015
Aalto Scientific Ltd. c/o Mr. Robert Burda Regulatory Affairs Manager 1959 Kellogg Avenue Carlsbad, CA 92008
Re: K143573
Trade/Device Name: Audit® MicroControls™ FD Linearity Tumor Markers II Regulation Number: 21 §CFR 862.1660 Regulation Name: Ouality Control Material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Code: JJY Dated: December 12, 2014 Received: December 17, 2014
Dear Mr. Burda:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) 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 (21 CFR Part 801), 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/Resourcesfor You/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,
Leonthena R. Carrington -A
Leonthena Carrington, MS, MBA, MT (ASCP) Director (Acting) Division of Immunology and Hematology 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) K143573
Device Name
Audit® MicroControls™ Linearity FD Tumor Markers II
Indications for Use (Describe)
The Linearity FD Tumor Markers II 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 the following analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigen-total (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), Carbonic Anhydrase 27-29 (CA27-29)(BR), free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3).
The Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Aalto Scientific Ltd.
510(k) Summary
510(k) Summary - Audit® MicroControls™ Linearity FD Tumor Markers II
Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for determination of substantial equivalence.
The assigned 510(k) number: K143573
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 Prepared: January16, 2014
B. Device Identification
| Product Trade Name: | Audit® MicroControls™ Linearity FD TumorMarkers II |
|---|---|
| Common Name: | Multi-Analyte Controls, All Kinds (Assayed andUnassayed) |
| Review Panel: | Clinical Chemistry |
| Device Classification: | Class I, Reserved |
| Product Code: | JJY |
| Regulation Number: | 21CFR862.1660 |
C. Device to Which Substantial Equivalence is Claimed
K082717 Audit® MicroCV™ Tumor Markers Linearity Set
D. Intended Use
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The Linearity FD Tumor Markers II 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 the following analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigen-total (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), Carbonic Anhydrase 27-29 (CA27-29)(BR), free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3).
The Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.
| Characteristics | Audit® MicroControls™Linearity FD Tumor MarkersII(New Device) | Audit® MicroCV™ TumorMarkers Linearity Set(Predicate Device,K082717) |
|---|---|---|
| Intended Use | The Linearity FD TumorMarkers II is an assayedquality control materialintended to simulate humanpatient samples for use indetermining linearity,calibration verification, andthe verification of reportablerange for the followinganalytes: Alpha fetoprotein(AFP), Carcinoembryonicantigen (CEA), Prostate-specific antigen-total (PSA),Carbonic Anhydrase-125(CA-125), CarbonicAnhydrase 19-9 (CA19-9),Carbonic Anhydrase 27-29(CA27-29)/(BR), free-PSA(fPSA), and CarbonicAnhydrase 15-3 (CA15-3).The Linearity FD TumorMarkers II is for In VitroDiagnostic use only. | The Audit™ MicroCV™Tumor Markers LinearitySet consists of five levels inHuman based serum. Eachlevel contains the followinganalytes: Alpha fetoprotein(AFP), Carcinoembryonicantigen (CEA), CA-125,CA15-3, Prostate specificantigen-free (free PSA),total PSA. The five levelsdemonstrate a linearrelationship to each otherfor their respective analytes,reagents, and instruments.This product may be usedfor proficiency testing ininterlaboratory surveys. |
| Number ofLevels per Set | 5 | 5 |
| Contents | 5x1ml (two sets) | 5x1ml (one set) |
| Matrix | Human Based Serum andbovine based serum | Human Based Serum |
| Type of | Clinical Chemistry | Clinical Chemistry |
E. Technical Characteristics Compared to Predicate Device
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| Analytes | ||
|---|---|---|
| Form | Freeze Dried | Freeze Dried |
| Storage | 2-8°C | 2-8°C |
| ReconstitutedStability | fPSA-7 days at 2-8°C,Remaining analytes-14 daysat 2-8°C | 7 days at 2-8°C |
| Sterile | No | No |
| Analytes | AFP, CEA, CA-125, CA15-3,fPSA, total PSA, CA19-9,CA27-9 | AFP, CEA, CA-125,CA15-3, fPSA, total PSA |
| Number ofAnalytes perVial | 6 (Set 1) and 2 (Set 2) | 6 |
F. Device Description
The Audit® MicroControls™ Linearity FD Tumor Markers II product is an in-vitro diagnostic device consisting of two sets of five levels of liquid, linearity/QC material. Set 1 contains the analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigentotal (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), and Carbonic Anhydrase 27-29 (CA27-29) (BR) and additives in human serum. Set 2 contains the analytes: free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3) and additives in human serum and bovine serum. For each set there are five levels labeled A, B, C, D and E. Both sets 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
Analyte value assignment for Level A through Level E was performed on Siemens Advia Centaur for the analytes: AFP, CEA, PSA, CA125, CA27-29 (BR), and CA15-3 using the corresponding reagent. Analyte value assignment for the analytes: CA19-9. and free-PSA were performed on Abbott Architect i1000SR using the corresponding reagent. Each analyte was measured multiple times. The mean value of each analyte was used to establish target concentration value at each level. All supporting data is retained on file at Aalto Scientific, Ltd.
AMR
- AFP: 1.3-1000 ng/ml CEA: 0.5-100ng/ml PSA: 0.01-1000 ng/ml CA125: 2-600 U CA27-29 (BR): 3.5-450 U/ml CA15-3: 0.5-200 U/ml CA19-9: 1.2-1200 U/ml fPSA: 0.008-30 ng/ml
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H. Summary of Performance Data
Stability studies have been performed to determine the reconstituted vial stability and shelf life for the Audit® MicroControls™ Linearity FD Tumor Markers II.
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: 2 years, 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 two 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 Day0 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 Stability: Once a vial has been opened and reconstituted, the product will be stable for 14 days when stored tightly capped at 2-8° C.
I. Expected Values
Value assignment of Audit® MicroControls™ Linearity FD Tumor Markers II have been performed to determine the expected values of the AFP, CEA, CA-125, CA15-3, fPSA, total PSA, CA19-9, CA27-9 analytes. Each analyte value assignment for Level A through Level E was performed on Siemens Advia Centaur using the corresponding reagents for AFP, CEA, PSA, CA125, CA27-29 (BR), and CA15-3. Each analyte value assignment for Level A through Level E was performed on Abbott Architect i1000SR using the corresponding reagent for CA19-9, and free-PSA. Each analyte was measured multiple times and the mean value of each analyte was used to establish target values at each level. The target ranges were calculated as +/-20% 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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| AFP (ng/ml)/Siemens Advia Centaur | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Level A | Level B | Level C | Level D | Level E | ||||||
| Target value | Target Range | Target value | Target Range | Target value | Target Range | Target value | Target Range | Target value | Target Range | |
| 8.2 | 6.5-9.8 | 264.5 | 211.6-317.4 | 515.4 | 412.3-618.5 | 785.1 | 628.1-942.1 | 1030.7 | 824.5-1236.8 | |
| CEA (ng/ml)/Siemens Advia Centaur | ||||||||||
| Level A | Level B | Level C | Level D | Level E | ||||||
| Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | |
| 3.01 | 2.41-3.62 | 29.36 | 23.49-35.24 | 54.99 | 43.99-65.99 | 76.86 | 61.49-92.23 | 106.89 | 85.51-128.27 |
CEA (ng/ml)/Siemens Advia Centaur
| PSA (ng/ml)/Siemens Advia Centaur | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Level A | Level B | Level C | Level D | Level E | |||||
| Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange |
| 0.22 | 0.18-0.27 | 27.71 | 22.17-33.25 | 57.12 | 45.70-68.55 | 85.87 | 68.69-103.04 | 115.07 | 92.05-138.08 |
| CA125 (U/ml)/Siemens Advia Centaur | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Level A | Level B | Level C | Level D | Level E | |||||
| Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange |
| 11.0 | 8.8-13.2 | 162.4 | 129.9-194.8 | 302.3 | 241.8-362.7 | 464.9 | 371.9-557.9 | 620.1 | 496.1-744.1 |
| CA27-29 (U/ml)/Siemens Advia Centaur | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Level A | Level B | Level C | Level D | Level E | ||||||
| Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | |
| 11.61 | 9.29-13.93 | 114.97 | 91.98-137.96 | 222.32 | 177.85-266.78 | 320.85 | 256.68-385.02 | 429.50 | 343.60-515.40 |
| CA15-3 (U/ml)/Siemens Advia Centaur | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Level A | Level B | Level C | Level D | Level E | |||||
| Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange |
| 1.3 | 1.1-1.6 | 50.6 | 40.5-60.8 | 100.9 | 80.7-121.1 | 145.5 | 116.4-174.6 | 200.1 | 160.0-240.1 |
| CA19-9 (U/ml)/Abbott Architect i1000SR | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Level A | Level B | Level C | Level D | Level E | ||||||
| Targetvalue | Target Range | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | Targetvalue | TargetRange | |
| 7.01 | 5.60-8.41 | 295.48 | 236.38-354.57 | 594.98 | 475.98-713.98 | 878.37 | 702.70-1054.04 | 1143.61 | 914.89-1372.34 |
| free-PSA (ng/ml)/Abbott Architect i1000SR | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Level A | Level B | Level C | Level D | Level E | |||||
| Targetvalue | Target Range | Targetvalue | Target Range | Targetvalue | Target Range | Targetvalue | Target Range | Targetvalue | Target Range |
| 0.016 | 0.013-0.019 | 7.533 | 6.026-9.039 | 16.083 | 12.866-19.299 | 25.475 | 20.380-30.570 | 32.219 | 25.775-38.663 |
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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.