(29 days)
IDS-iSYS 17-OH Progesterone Control Set
The IDS-iSYS 17-OH Progesterone Control Set is for in vitro diagnostic use, for the quality control of the IDS-iSYS 17-OH Progesterone on the IDS-iSYS Multi-Discipline Automated System.
Rx Only.
IDS-iSYS 17-OH Progesterone Calibration Verifiers
The IDS-iSYS 17-OH Progesterone Calibration Verifiers are an in vitro diagnostic device intended for medical purposes in the quantitative verification of assay calibration and measuring range of the IDS-iSYS 17-OH Progesterone assay, when performed on the IDS-iSYS Multi Discipline Automated System.
Rx Only.
The IDS-iSYS 17-OH Progesterone Control Set consists of Two sets of three vials, 1.0 mL each in liquid form. Human serum containing 17-OH Progesterone and sodium azide as a preservative (<0.1%), with three concentration levels.
The IDS-iSYS 17-OH Progesterone Calibration Verifiers consists of Four calibration verifier levels in liquid form (two 1.0mL vials for level 0 and one 1.0mL vial for levels 1, 2 & 3). Human serum containing 17-OH Progesterone and sodium azide as a preservative (<0.1%), with three concentration levels.
The provided text describes the acceptance criteria and supporting studies for two in vitro diagnostic devices: the IDS-iSYS 17-OH Progesterone Control Set and the IDS-iSYS 17-OH Progesterone Calibration Verifiers.
1. Table of acceptance criteria and the reported device performance:
| Study Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Control Set | ||
| Value Assignment | Assigned target value defined as the mean of all runs for the IDS-iSYS 17-OH Progesterone assay and analyzer. | Expected values: Low control: 2.0 ng/mL, Medium control: 5.0 ng/mL, High control: 10.0 ng/mL. (The study provides these as the expected values, which implies they were achieved, but does not explicitly re-state them as performance against the criteria beyond the definition of the target value.) |
| Closed Vial Stability | - Mean concentration must be within QC ranges (as stated in Certificate of Analysis)- Precision: CV ≤ 10% for low concentration, ≤ 8% for middle and high concentration | - Accelerated stability studies (CLSI guideline EP25-A) support a stability claim of 9 months when stored at 2-8°C.- Real-time studies are ongoing. (No explicit statement if current readings meet the mean concentration and precision criteria for the 9-month claim, only that it "supports" it). |
| Open Vial Stability | Percent recoveries within 10% of the reference material concentration. | Data supports the open vial stability claim of 49 days when stored at 2-8°C. (Implies the 10% recovery criterion was met). |
| On-Board Stability | Compared to a reference material run at time 0. (Specific quantitative criteria not explicitly stated, assumes comparison ensures acceptable performance.) | The on-board stability data supports the claimed on-board stability of 4 hours. (Implies acceptable comparison results). |
| Calibration Verifiers | ||
| Value Assignment | Assigned target value defined as the mean of all runs for the IDS-iSYS 17-OH Progesterone assay and analyzer. | Expected values: Cal Ver 0: Undetectable, Cal Ver 1: 2.0 ng/mL, Cal Ver 2: 8.0 ng/mL, Cal Ver 3: 17.0 ng/mL. (Similar to control set, implies these were achieved.) |
| Closed Vial Stability | - Mean concentration must be within QC ranges (as stated in Certificate of Analysis)- Precision: CV ≤ 10% for low concentration, ≤ 8% for middle and high concentration | - Accelerated stability studies (CLSI guideline EP25-A) support a stability claim of 9 months when stored at 2-8°C.- Real-time studies are ongoing. (No explicit statement if current readings meet the mean concentration and precision criteria for the 9-month claim, only that it "supports" it). |
| On-Board Stability | Compared to a reference material run at time 0. (Specific quantitative criteria not explicitly stated, assumes comparison ensures acceptable performance.) | The on-board stability data supports the claimed on-board stability of 4 hours. (Implies acceptable comparison results). |
2. Sample size used for the test set and the data provenance:
- IDS-iSYS 17-OH Progesterone Control Set - Value Assignment:
- Sample Size: A minimum of 21 runs using cartridge batches (number of batches not specified) tested in triplicate on each of three IDS-iSYS Multi Discipline Automated Systems. Control solutions were prepared gravimetrically.
- Data Provenance: Not explicitly stated as retrospective or prospective, nor country of origin. Given it's a device manufacturer's study to establish product characteristics, it's inherently prospective in nature.
- IDS-iSYS 17-OH Progesterone Control Set - Stability (All types):
- Closed Vial (Real-time): Three lots of controls, tested in pentaplicate (5 replicates) at 2-month intervals for up to a minimum of 15 months. Each tested vial compared to reference material stored at -20°C.
- Closed Vial (Accelerated): Performed according to CLSI guideline EP25-A.
- Open Vial: Tested in duplicate at time points stated in the stability protocol (time points not detailed), against unopened vials.
- On-Board: Three batches of controls, using three IDS-iSYS instruments. Tested at 0, 2, 4, 6, and 8 hours compared to a reference material at time 0.
- Data Provenance: Same as above, likely prospective internal testing.
- IDS-iSYS 17-OH Progesterone Calibration Verifiers - Value Assignment:
- Sample Size: Minimum of five runs for each cartridge batch (number of batches not specified) tested in triplicate on each of three IDS-iSYS Multi Discipline Automated Systems. Calibration Verifier solutions were prepared gravimetrically.
- Data Provenance: Same as above, likely prospective internal testing.
- IDS-iSYS 17-OH Progesterone Calibration Verifiers - Stability (Closed Vial & On-Board):
- Closed Vial (Real-time): Three lots of calibration verifiers, tested in pentaplicate (5 replicates) at 2-month intervals for up to a minimum of 15 months.
- Closed Vial (Accelerated): Performed according to CLSI guideline EP25-A.
- On-Board: Three batches of calibration verifiers, using three IDS-iSYS instruments. Tested at 0, 2, 4, 6, and 8 hours compared to a reference material at time 0.
- Data Provenance: Same as above, likely prospective internal testing.
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 device is an in vitro diagnostic (IVD) quality control material and calibration verifier for automated systems, not an imaging AI device. The "ground truth" here refers to the reference values established for the control and calibration materials themselves, rather than diagnosis or interpretation by human experts.
- Value Assignment: The "ground truth" (assigned target values) for both the control set and calibration verifiers is established by the mean of all runs from multiple tests on three IDS-iSYS Multi Discipline Automated Systems, using cartridge batches, and confirmed by immunologic analysis using the IDS-iSYS 17-OH Progesterone assay. The solutions themselves are prepared gravimetrically from intermediate stock solutions.
- There are no "experts" in the traditional sense (e.g., radiologists) involved in establishing the ground truth for this type of chemical/immunological assay. The ground truth relies on the precision and accuracy of the analytical methods and the instrument itself.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human interpretation or subjective assessment of data that would require an adjudication method. The device's performance is determined by quantitative measurements and statistical analysis against predefined criteria.
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 device is an IVD quality control and calibration material, not an AI-powered diagnostic tool for human readers. No MRMC study was conducted or is relevant for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the studies are inherently standalone as they evaluate the performance of the control and calibration materials on the IDS-iSYS Multi-Discipline Automated System. The system/assay performs the measurements without human intervention in the interpretation of the control/verifier results themselves beyond setting up the experiment and analyzing statistical compliance. The performance reported (e.g., mean concentration, CV, percent recovery) is that of the material as measured by the automated system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used is based on:
- Gravimetric preparation: For the initial stock solutions and preparation of control/calibration verifier samples.
- Immunologic analysis: Confirmation of concentrations using the IDS-iSYS 17-OH Progesterone assay itself.
- Statistical averaging: The mean of multiple runs on multiple instruments to establish the assigned target values, treated as the reference ground truth for quality control and calibration verification.
- Reference material comparison: For stability studies, comparison to a reference control material stored under optimal conditions (-20°C).
This is a form of analytical ground truth derived from established quantitative laboratory methods and statistical analysis rather than clinical consensus or pathological diagnosis.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set. The values and stability characteristics are determined through direct analytical testing, not model training.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/machine learning model, no ground truth needed to be established for it.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2016
IMMUNODIAGNOSTIC SYSTEMS LTD. MICK HENDERSON, REGULATORY AFFAIRS OFFICER 10 DIDCOT WAY, BOLDEN BUSINESS PARK BOLDON, TYNE & WEAR, NE35 9PD UNITED KINGDOM
Re: K161082
Trade/Device Name: IDS-iSYS 17-OH Progesterone Control Set. IDS-iSYS 17-OH Progesterone Calibration Verifiers Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJX Dated: April 15, 2016 Received: April 18, 2016
Dear Mick Henderson:
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 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulations (21 CFR 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" (21 CFR 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
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161082
Device Name
IDS-iSYS 17-OH Progesterone Control Set IDS-iSYS 17-OH Progesterone Calibration Verifiers
Indications for Use (Describe) IDS-iSYS 17-OH Progesterone Control Set
The IDS-iSYS 17-OH Progesterone Control Set is for in vitro diagnostic use, for the quality control of the IDS-iSYS 17-OH Progesterone on the IDS-iSYS Multi-Discipline Automated System.
Rx Only.
IDS-iSYS 17-OH Progesterone Calibration Verifiers
The IDS-iSYS 17-OH Progesterone Calibration Verifiers are an in vitro diagnostic device intended for medical purposes in the quantitative verification of assay calibration and measuring range of the IDS-iSYS 17-OH Progesterone assay, when performed on the IDS-iSYS Multi Discipline Automated System.
Rx Only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The |
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY
| Introduction | According to the requirements of 21CFR807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| Submitter | Immunodiagnostic Systems Ltd10 Didcot WayBoldon Business ParkBoldonTyne and WearNE35 9PDUnited Kingdom |
| Contact Person: | Mick HendersonPhone: +44 191 5190660Fax: +44 191 5190760Email: mick.henderson@idsplc.com |
| Secondary Contact: | Samantha RannPhone: +44 191 5190660Fax: +44 191 5190760Email: samantha.rann@idsplc.com |
| Date Prepared: | 12th May 2016 |
| Device Name: | Proprietary names: IDS-iSYS 17-OH Progesterone Control SetModel No. IS-5130IDS-iSYS 17-OH ProgesteroneCalibration VerifiersModel No. IS-5135Common names: As aboveClassification: 21CFR862.1660 (Class I, Reserved)Product Code: JJX |
| Device Descriptions: | The IDS-iSYS 17-OH Progesterone Control Set consists of Two sets of three vials, 1.0 mL each in liquid form. Human serum containing 17-OH Progesterone and sodium azide as a preservative (<0.1%), with three concentration levels.The IDS-iSYS 17-OH Progesterone Calibration Verifiers consists of |
| Four calibration verifier levels in liquid form (two 1.0mL vialsfor level 0 and one 1.0mL vial for levels 1, 2 & 3).Human serum containing 17-OH Progesterone and sodiumazide as a preservative (<0.1%), with three concentrationlevels. | |
| Predicate Devices: | IDS-iSYS CTX-I (CrossLaps®) Control SetIDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers |
| Predicates 510(k): | K111650 |
| Special Conditionsfor Use: | For in vitro diagnostic use.Rx Only |
| Special instrumentRequirements: | IDS-iSYS Multi-Discipline Automated System (K091849) |
| Intended Use: | The IDS-iSYS 17-OH Progesterone Control Set is for in vitrodiagnostic use, for the quality control of the IDS-iSYS 17-OHProgesterone on the IDS-iSYS Multi-Discipline AutomatedSystem.RX OnlyThe IDS-iSYS 17-OH Progesterone Calibration Verifiers are anin vitro diagnostic device intended for medical purposes in thequantitative verification of assay calibration and measuringrange of the IDS-iSYS 17-OH Progesterone assay, whenperformed on the IDS-iSYS Multi Discipline AutomatedSystem.Rx Only. |
| Comparison with predicate:17OH-Progesterone Control Set | Similarities and differences compared to the chosen predicate device - |
{4}------------------------------------------------
Similarities and differences compared to the chosen predicate device:IDS-iSYS CTX-I (CrossLaps®) Control Set (K111650)
| Performance | Predicate Device: IDS-iSYS CTX-I (CrossLaps®)Control Set (K111650) | Candidate Device: IDS-iSYS17-OH Progesterone ControlSet |
|---|---|---|
| Indications for Use | Used for quality control of | Used for quality control of the |
{5}------------------------------------------------
| the IDS-iSYS CTX-I(CrossLaps®) Assay. | IDS-iSYS 17-OHProgesterone Assay. | |
|---|---|---|
| Analyte | CTX-I | 17-OH Progesterone |
| Concentrations | Low control: 0.2ng/mL.Medium Control: 0.8ng/mL.High Control: 2ng/mL. | Low control: 2.0ng/mL.Medium Control: 5.0ng/mL.High Control: 10.0ng/mL. |
| Analyzer System | IDS-iSYS Multi-DisciplineAutomated System | Same |
| Stability and storage | 2-8°C – unopened untilexpiration date | Same |
| After opening: stable for 28days at 4°C | After opening: stable for 49days at 2-8°C | |
| On board stability: 3 hours | On board stability: 4 hours | |
| Matrix | Liquid, phosphate bovineserum albumin | Human serum |
170H-Progesterone Calibration Verifiers
Similarities and differences compared to the chosen predicate device:-
IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers (K111650)
| Performance | Predicate Device: IDS-iSYS CTX-I (CrossLaps®)Calibration Verifiers(K111650) | Candidate Device: IDS-iSYS17-OH ProgesteroneCalibration Verifiers |
|---|---|---|
| Indications for Use | Used for the quantitativeverification of calibration ofthe IDS-iSYS CTX-I(CrossLaps®) assay. | Used for the quantitativeverification of calibration ofthe IDS-iSYS 17-OHProgesterone assay. |
| Levels | Levels 0, 1, 2 & 3 | Same |
| Matrix | Liquid, phosphate bovineserum albumin | Human serum |
| Stability and Storage | 2-8°C – unopened untilexpiration dateOn board stability: SingleUse - use then discard | Same |
{6}------------------------------------------------
| Analyte | CTX-I | 17-OHProgesterone |
|---|---|---|
| Concentrations | 0.0ng/mL, 0.6ng/mL,3.0ng/mL and 5.0ng/mL | Cal Ver 0: UndetectableCal Ver 1: 2.0ng/mLCal Ver 2: 8.0 ng/mLCal Ver 3: 17.0ng/mL |
| Analyzer System | IDS-iSYS Multi-DisciplineAutomated System | Same |
Performance Characteristics
IDS-iSYS 17-OH Progesterone Control Set
Value Assignment
Each control level is tested on three IDS-iSYS Multi Discipline Automated Systems with a minimum of 21runs using cartridge batches available tested in triplicate. Control solutions are prepared gravimetrically from an intermediate stock solution and concentrations are confirmed by immunologic analysis using IDS-iSYS 17-0H Progesterone assay on IDS-iSYS Multi Discipline Automated System. In the value assignment process, controls were calibrated using a master calibrator to generate a master curve. The assigned target value of each control level is defined as the mean of all the runs for the IDS-iSYS 17-OH Progesterone assay and analyzer. The following are the expected values for each level of control: 2.0 ng/mL, 5.0 ng/mL and 10.0 ng/mL.
Stability
Closed vial:
For the real time closed vial testing, three lots of controls were stored at 4°C.
Each control material will be tested in pentaplicate in 2 month intervals for up to a minimum of 15 months. Each control vial tested will be compared back to reference control material stored at -20°C. Controls must be within acceptance criteria defined as below:
-
mean concentration must be within QC ranges (as stated in the Certificate of Analysis)
-
precision: CV ≤ 10% for low concentration - ≤ 8% for middle and high concentration
To date, accelerated stability studies performed according to the CLSI guideline EP25-A (Evaluation of stability of In Vitro Diagnostic Reagents) support a stability claim of 9 months when stored at 2-8°C.
Real time stability studies in accordance with the CLSI guideline EP25-A (Evaluation of stability of In Vitro Diagnostic Reagents) to support the above claims are ongoing.
Open Vial:
Open vial (in-use) stability of controls were performed at 4℃ and tested against unopened vials of control material stored at 4°C. Controls were tested in duplicate at the time points stated in the stability protocol. Percent recoveries of each material
{7}------------------------------------------------
were within the acceptance criteria of 10% of the reference material concentration. Data supports the open vial stability claim of 49 days when stored at 2-8°C.
On-Board:
On-board stability studies were performed using three batches of controls using three IDS-iSYS instruments. Controls were tested at time 0, 2 hours, 4 hours, 6 hours and 8 hours and compared to a reference material run at time 0. The on board stability data supports the claimed on-board stability of 4 hours.
IDS-iSYS 17-OH Progesterone Calibration Verifiers
Value Assignment
Each calibration verifier level is tested on three IDS-iSYS Multi Discipline Automated Systems with a minimum of five runs for each cartridge batch tested in triplicate. Calibration Verifiers solutions are prepared gravimetrically from an intermediate stock solution and concentrations are confirmed by immunologic analysis using IDS-iSYS 17-0H Progesterone assay on IDS-iSYS Multi Discipline Automated System. In the value assignment process, calibration verifiers were calibrated using a master calibrator to generate a master curve. The assigned target value of each calibration verifier level is defined as the mean of all the runs for the IDS-iSYS 17-OH Progesterone assay and analyzer. The following are the expected values for each level of calibration verifier: 2.0 ng/mL, 8.0 ng/mL, and 17.0 ng/mL.
Stability
For the real time closed vial testing, three lots of calibration verifiers will be stored at 4°C. Each calibration verifier will be tested in pentaplicate in 2 month intervals for up to a minimum of 15 months.
Calibration verifiers must be within acceptance criteria defined as below:
-
mean concentration must be within QC ranges (as stated in the Certificate of Analysis)
-
precision: CV ≤ 10% for low concentration - ≤ 8% for middle and high concentration
To date, accelerated stability studies performed according to the CLSI guideline EP25-A (Evaluation of stability of In Vitro Diagnostic Reagents) support a stability claim of 9 months when stored at 2-8°C.
Real time stability studies in accordance with the CLSI guideline EP25-A (Evaluation of stability of In Vitro Diagnostic Reagents) to support the above claims are ongoing.
On-Board:
On-board stability studies were performed using three batches of calibration verifiers using three IDS-iSYS instruments. Calibration verifiers were tested at time 0, 2 hours,
{8}------------------------------------------------
4 hours, 6 hours and 8 hours and compared to a reference material run at time 0. The on board stability data supports the claimed on-board stability of 4 hours.
Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
§ 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.