(40 days)
Liquichek Ethanol/Ammonia Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Liquichek Ethanol/Ammonia Control is prepared from bovine serum albumin with chemicals, stabilizers and preservatives added. This control is provided in liquid form for convenience.
The provided document is a 510(k) Premarket Notification for a Liquichek Ethanol/Ammonia Control, which is a quality control material used to monitor the precision of laboratory testing procedures. This is not a medical device that utilizes AI or machine learning, nor is it designed for diagnostic imaging or similar applications where the requested information (like MRMC studies, human reader improvement, or expert ground truth establishment) would be relevant.
Therefore, many of the requested categories about acceptance criteria and study design are not applicable to this type of product. The document describes a traditional medical device (a control solution) that undergoes stability testing, not a device that involves complex algorithms or human interpretation of outputs.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" in the format typically seen for diagnostic devices (e.g., sensitivity, specificity thresholds). Instead, it describes "stability studies" performed to determine shelf-life and open-vial stability. The "reported device performance" is the claim of stability for these periods.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Stability of analyte levels within acceptable ranges over time. | Open Vial Stability: 20 days at 2 to 8°C on board Siemens Dimension Vista instrument |
| Shelf-life stability for the product. | Shelf Life Stability: 24 Months at 2 to 8°C |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an algorithm or diagnostic evaluation. The stability studies likely involved multiple aliquots or batches of the control material over the specified periods.
- Sample Size: Not explicitly stated, but implies "replicate analyses" and "a representative sampling of this lot of product."
- Data Provenance: The studies were performed by the manufacturer (Bio-Rad Laboratories) and/or independent laboratories. No country of origin for the data is specified, but the manufacturer is based in Irvine, California, USA. The studies are prospective in nature, as they are establishing future stability claims.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This concept is not applicable to a quality control material. Ground truth in this context would refer to the true concentration of ethanol and ammonia, which is established by precise laboratory methods and analytical chemistry, not by human expert interpretation. The "value assignment" section states that mean values and ±3SD ranges were "derived from replicate analyses" by the manufacturer and independent laboratories.
4. Adjudication Method for the Test Set
This is not applicable. The "test set" in this context refers to samples used for analytical stability studies, not for the evaluation of a diagnostic algorithm's output that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. This type of study is designed for diagnostic devices that are interpreted by human readers, often with AI assistance. The Liquichek Ethanol/Ammonia Control is a quality control solution for laboratory instruments, not a device that human readers interact with in this manner.
6. Standalone Performance Study
This is not applicable in the sense of an algorithm operating independently. The "performance" of this device is its ability to maintain stable concentrations of ethanol and ammonia over time, which is assessed through laboratory testing of the control material itself (standalone in that sense, but not for an algorithm).
7. Type of Ground Truth Used
The ground truth for this device (the true values of Ethanol and Ammonia) is established through analytical testing and measurement using laboratory instruments specified in the value assignment section. It's based on precise chemical analysis, not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
This is not applicable. There is no "training set" as this device is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
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K1231'98
Bio-Rad Laboratories Premarket Notification Section 510 (k) Liquichek Ethanol/Ammonia Control
Page 1 of 3
Summary of Safety and Effectiveness Liquichek Ethanol/Ammonia Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1557
Contact Person
Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467
Date of Summary Preparation
November 15, 2012
2.0 Device Identification
| Product Trade Name: | Liquichek Ethanol/Ammonia Control |
|---|---|
| Common Name: | Multi-Analyte Controls, All Kinds (Assayed) |
| Classifications: | Class I, Reserved |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
| Predicate Device Information | |
|---|---|
| Device Name: | Liquichek Ethanol/Ammonia Control |
| Applicant: | Bio-Rad Laboratories |
| 510(k) Number: | K955024 |
| Product Code: | JJY |
| Regulation #: | 862.1660 |
| Device Classification Name: | Multi-analyte Controls. All Kinds(Assayed) |
4.0 Description of Device
Liquichek Ethanol/Ammonia Control is prepared from bovine serum albumin with chemicals, stabilizers and preservatives added. This control is provided in liquid form for convenience.
5.0 Intended Use
Liquichek Ethanol/Ammonia Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
NOV 2 0 2012
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6.0 Value Assignment
The mean values and the corresponding ±3SD ranges printed in this insert were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as quides. Laboratory established ranges may vary from those listed during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications
7.0 Comparison of the new device with the Predicate Device
Liquichek Ethanol/Ammonia Control claims substantial equivalence to the Liquichek Ethanol/Ammonia Control currently in commercial distribution under 510(k)K95024. Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.
| Characteristics | Liquichek Ethanol/Ammonia Control(New Device) | Liquichek Ethanol/Ammonia Control(Predicate Device under K955024) |
|---|---|---|
| Similarities | ||
| Intended Use | Liquichek Ethanol/Ammonia Control isintended for use as an assayed qualitycontrol serum to monitor the precision oflaboratory testing procedures for theanalytes listed in this package insert. | Liquichek Ethanol/Ammonia Control isintended for use as an assayed qualitycontrol serum to monitor the precision oflaboratory testing procedures for theanalytes listed in this package insert. |
| Matrix | This product is prepared from bovineserum albumin with added chemicals,stabilizers and preservatives. | This product is prepared from bovineserum albumin with added chemicals,stabilizers and preservatives. |
| Form | Liquid | Liquid |
| Storage unopened(Shelf life) | Until the expiration date when stored at2 to 8°C | Until the expiration date when stored at2 to 8°C |
| Analytes | EthanolAmmonia | EthanolAmmonia |
| Differences | ||
| Fill Size | 2.5 mL | 3 mL |
| Open Vial Stability | 20 days at 2 to 8°C on board SiemensDimension Vista instrument | 20 days at 2 to 8°C |
Table 1. Similarities and Differences between new and predicate device.
8.0 Statement of Supporting Data
Stability studies have been performed and met the acceptance criteria for Liquichek Ethanol/Ammonia Control (New Device) to determine the open vial and shelf life claims. Product claims are as follows:
Open Vial Stability:
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Sheif Life Stability
24 Months at 2 to 8°C
9.0 Conclusion
Liquichek Ethanol/Ammonia Control (New Device) is intended to be used for the same intended use as the predicate. It has bovine serum albumin matrix and performs similarly as the predicate device
All supporting data is retained on file at Bio-Rad Laboratories.
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DEPARTMENT OF HEALTH & HUM AN SERVICES
Image /page/3/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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 20, 2012
Bio-Rad Laboratories c/o Suzanne Parsons 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K123198
Trade/Device Name: Liquichek Ethanol/Ammonia Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved Product Code: JJY Dated: October 8, 201-2 Received: October 25, 2012
Dear Ms. Suzanne Parsons:
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.
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 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.
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Page 2 - Suzanne Parsons
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benson
for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
123198 510(k) Number (if known):
Liquichek Ethanol/Ammonia Control Device Name:
Indications for Use:
Liquichek Ethanol/Ammonia Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
The following analytes are included in the package insert:
- Ethanol 2. Ammonia
X Over-The-Counter Use Prescription Use Prescription Ose
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung. Chan
Division/Sign-Office of In Vitro Diagnostics and Radiological Health
510(k) k123i98
§ 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.