(28 days)
For use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Lyphochek Assayed Chemistry Control is prepared from human serum with added constituents of purified biochemicals (tissue extracts of human and animal origin), chemicals, therapeutic drugs, preservatives and stabilizers. The control is provided in lyophilized form.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Lyphochek Assayed Chemistry Control device:
Important Note: The provided document is a 510(k) summary for a diagnostic quality control material. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study demonstrating diagnostic performance against a ground truth for individual disease detection. The "device performance" in this context refers to the stability and claims for the control material itself.
Acceptance Criteria and Study for Lyphochek Assayed Chemistry Control
The Lyphochek Assayed Chemistry Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures. The "acceptance criteria" and "device performance" are related to the stability of the control material over various conditions (open vial, after reconstitution and freezing, and shelf life).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability | All analytes stable for 7 days at 2 to 8°C | All analytes are stable for 7 days at 2 to 8°C. |
| Acid Phosphatase stable for 3 days at 2 to 8°C. | Acid Phosphatase is stable for 3 days at 2 to 8°C. | |
| Prostatic Acid Phosphatase stable for 3 days at 2 to 8°C. | Prostatic Acid Phosphatase is stable for 3 days at 2 to 8°C. | |
| Reconstituted & Frozen Stability | All analytes stable for 30 days when stored at -10 to -20°C. | All analytes are stable for 30 days when stored at -10 to -20°C. |
| Tobramycin stable for 20 days when stored at -10 to -20°C. | Tobramycin is stable for 20 days when stored at -10 to -20°C. | |
| Shelf Life | Sufficient stability for market distribution. | 3 Years + 4 Months at 2 to 8°C. Real-time studies are ongoing to support this claim. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the traditional sense of patient samples for a diagnostic device. It refers to stability studies of the control material itself. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) for patient data is not applicable here. The data provenance relates to the internal studies conducted by Bio-Rad Laboratories for the stability of their product.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable to this type of device. The "ground truth" for a quality control material is its stability and the accuracy of its assigned values, determined through internal manufacturing and quality control processes rather than expert clinical review.
4. Adjudication Method for the Test Set
This is not applicable. There is no "test set" of patient data requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. The device is a quality control material, not a diagnostic tool requiring human interpretation or a comparative effectiveness study with human readers.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable. The device is not an algorithm. Its performance is evaluated by its physical and chemical stability characteristics under various conditions.
7. Type of Ground Truth Used
The "ground truth" for a quality control material like this is established through internal analytical testing and manufacturing specifications. This involves:
- Analytical measurements: Assaying the batch of control material using reference methods to determine the expected values for each analyte.
- Stability testing: Performing longitudinal studies to assess the consistency of these values over time and under different storage conditions (temperature, open/closed vial, frozen/reconstituted).
- Compliance with manufacturing specifications: Ensuring that the control material meets predefined limits for deviation, homogeneity, and integrity.
8. Sample Size for the Training Set
This is not applicable. The concept of a "training set" typically applies to AI/ML algorithms. For a quality control material, there isn't a training set in this context. The manufacturing process and formulation development could be seen as an ongoing "training" in a very broad sense, but not for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons mentioned above. For this device, "ground truth" is established by rigorous analytical chemistry and stability testing within Bio-Rad Laboratories' quality management system.
{0}------------------------------------------------
MAR - 4 2004
Summary of Safety and Effectiveness Lyphochek Assayed Chemistry Control
040273
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:
Contact Person
Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
January 23, 2004
2.0 Device Identification
| Product Trade Name: | Lyphochek Assayed Chemistry Control | |
|---|---|---|
| Common Name: | Quality Control Materials, all kinds (Assayed and Unassayed) | |
| Characteristics | Bio-RadLyphochek Assayed Chemistry Control(New Device) | Bio-RadLyphochek Assayed Chemistry Control(Predicate Device K874280) |
| Similarities | ||
| Intended Use | Lyphochek Assayed Chemistry 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. | Lyphochek Assayed Chemistry 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. |
| Form | Lyophilized | Lyophilized |
| Matrix | Serum | Serum |
| Storage(Unopened) | 2-8°C until expiration date | 2-8°C until expiration date |
| After Reconstitutionand Freezing | All analytes will be stable for 30 days when stored tightly capped at -10 to -20°C with the following exceptions: Tobramycin will be stable for 20 days | All analytes will be stable for 30 days when stored tightly capped at -10 to -20°C with the following exceptions: Tobramycin will be stable for 20 days |
| Differences | ||
| Open Vial | 7 days at 2 to 8°C with the following exceptions: Acid Phosphatase and Prostatic Acid Phosphatase will be stable for 3 days. | 7 days at 2 to 8°C with the following exceptions: Acid Phosphatase, Prostatic Acid Phosphatase and Alkaline Phosphatase will be stable for 3 days. |
| Analytes | Same as the predicate device with the following exceptions:Does not contain claims for:· Aldolase and FolateContains claims for the following additional analytes:· Calcium (Ionized)· Copper· Glutamate Dehydrogenase (GLDH)· Globulin· Cholesterol (LDL)· Iron-Binding Capacity, Total (TIBC)· Iron Binding Capacity, Unsaturated (UIBC)· T3 Free· T4 Free· Transferrin· Vitamin B12· Zinc | AcetaminophenAcid Phosphatase, TotalAlanine Aminotransferase (ALT)AlbuminAldolaceAlkaline Phosphatase (ALP)$\alpha$ HBDHAlpha-1-AntitrypsinAlpha-Fetoprotein (AFP)AmylaseAmylase, AlphaAmylase, PancreaticApolipoprotein A-1Apolipoprotein BAspartate Aminotransferase (AST/SGOT)Bilirubin, DirectBilirubin, IndirectBilirubin, TotalC3 ComplementC4 ComplementCalciumCarbamazepineCarbon Dioxide (CO2)Carcinoembryonic Antigen (CEA)CeruloplasminChlorideCholesterol, High Density Lipoprotein (HDL)Cholesterol, TotalCholinesteraseCortisolCreatine Kinase (CK)CreatinineDigoxinFolateGamma Glutamyltransferase (GGT)GentamicinGlucoseHaptoglobinImmunoglobulin A (IgA)Immunoglobulin G (IgG)Immunoglobulin M (IgM)IronLactate (Lactic Acid)Lactate Dehydrogenase (LDH)LAP - ArylamidaseLipaseLithiumMagnesiumOsmolalityPhenobarbitalPhenytoinPhosphorusPotassiumProstate Specific Antigen (PSA)Prostatic Acid Phosphatase (PAP)Protein ElectrophoresisProtein, TotalSalicylateSodiumT3 TotalT3 UptakeT4 TotalTheophyllineThyroid Stimulating Hormone (TSH)Thyroxine Binding Globulin (TBG)TobramycinTransferrinTriglyceridesUreaUrea NitrogenUric AcidValproic Acid |
Class I Classifications: JJY Product Code: CFR 862.1660 Regulation Number:
Device to Which Substantial Equivalence is Claimed 3.0
Lyphochek Assayed Chemistry Control Bio-Rad Laboratories Irvine, California
Docket Number: K87'4280
4.0 Description of Device
Lyphochek Assayed Chemistry Control is prepared from human serum with added constituents of purified biochemicals (tissue extracts of human and animal origin), chemicals, therapeutic drugs, preservatives and stabilizers. The control is provided in lyophilized form.
5.0 Statement of Intended Use
Lyphochek Assayed Chemistry 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.
Comparison of the new device with the Predicate Device 6.0
Lyphochek Assayed Chemistry Control claims substantial equivalence to the Lyphochek Assayed Chemistry Control currently in commercial distribution (K874280).
{1}------------------------------------------------
Table 1. Similarities and Differences between new and predicate device.
Statement of Supporting Data 7.0
Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek Assayed Chemistry Control. Product claims are as follows:
- Open vial: All analytes will be stable for 7 days at 2 to 8°C with the following exceptions: 7.1 Open vial Acid Prostatic Acid Phosphatase will be stable for 3 days.
{2}------------------------------------------------
- After reconstitution and freezing: All analytes will be stable for 30 days when stored at -7.2 ARCH Foodnetication of Tobramycin which will be stable for 20 days.
- Shelf Life: 3 Years + 4 Months at 2 to 8°C 7.3
- Real time studies will be ongoing to support the shelf life of this product. 7 4
All supporting data is retained on file at Bio-Rad Laboratories.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 figures, represented by flowing lines, symbolizing the department's focus on people and their well-being.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR - 4 2004
Ms. Elizabeth Platt Regulatory Affairs Manager/Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
K040273 Re:
Trade/Device Name: Lypochek Assayed Chemistry Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: January 23, 2004 Reccived: February 5, 2004
Dear Ms. Platt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have cletermined the device is substantially equivalent (for the indications for use stated in the enclosurc) 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, ate 1606 that 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 I ou mays arouvisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
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 or any I 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 (QS) regulation (21 CFR Part 820).
{4}------------------------------------------------
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his lotter will and in your e FDA finding of substantial equivalence of your device to a legally prematicated 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, rr you decire on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 I ou the) of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, 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
{5}------------------------------------------------
510 (k) Number (if known): _K040273
Lyphochek Assayed Chemistry Control Device Name:
Indications for Use:
For use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use or
Over-the Counter use
Carol C. Benson
Division Sign-Off
Office of In Vitro Dlagnostic Office Evaluation and Safety
510(k) K040273
§ 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.