(183 days)
Liquid Assayed Multiqual 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.
Liquid Assayed Multiqual is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Liquid Assayed Multiqual" device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds for a device, as one might find for a diagnostic test's sensitivity or specificity. Instead, it describes product claims related to stability, which serve as performance characteristics that the device is intended to meet. The study's purpose is to demonstrate that the new device meets these claims, and establishes substantial equivalence to a predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Open Vial Stability | 5 days at 2 to 8°C (This is the claim the device intends to meet and thus serves as the implicit acceptance criterion for this characteristic.) | "Open vial 5 days at 2 to 8°C" (The study performed stability studies to determine this claim, implying it was met.) |
| Thawed and Unopened | 30 days at 2 to 8°C, with exceptions: Direct Bilirubin 11 days, Triglycerides, HDL, Cholinesterase, Phosphorus 7 days. Total Bilirubin and Direct Bilirubin values may decrease, Alkaline Phosphatase activity may rise. (This is the claim the device intends to meet and thus serves as the implicit acceptance criterion for this characteristic.) | "Thawed and Unopened: 30 days at 2 to 8°C, with the following exceptions: Direct Bilirubin 11 days, Triglycerides, HDL, Cholinesterase, Phosphorus 7 days. Total Bilirubin and Direct Bilirubin values may decrease, Alkaline Phosphatase activity may rise." (The study performed stability studies to determine this claim, implying it was met.) |
| Shelf Life Stability | 3 Years at -20°C to -50°C (This is the claim the device intends to meet and thus serves as the implicit acceptance criterion for this characteristic.) | "Shelf Life Stability 3 Years at -20°C to -50°C" (The study performed stability studies to determine this claim, implying it was met.) |
| Substantial Equivalence | The new device performs "similarly" to the predicate device (K043208) as outlined by their identical intended use, physical form, matrix, and comparable stability claims, with noted differences in specific analyte stability and fill volume. | The report concludes: "Liquid Assayed Multiqual (new device) is intended to be used for the same purposes as the predicate device, it has the same human serum matrix and performs similarly as the predicate device." (This confirms the finding of substantial equivalence based on the comparison provided.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states, "The assigned values were derived from replicate analyses and are specific for each lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of the product lot."
- This indicates that a "representative sampling of the product lot" was used for testing, but the exact number of samples or the sample size (n) for the stability studies is not specified in this summary.
- Data Provenance: The studies were performed by the manufacturer (Bio-Rad Laboratories) and/or independent laboratories. The country of origin for the data is not explicitly stated, but Bio-Rad Laboratories is based in Irvine, California, suggesting the studies were likely conducted in the USA or by labs commissioned from the USA. The studies appear to be prospective in nature, as they were conducted to determine the stability claims for a new product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a quality control material used to monitor the precision of laboratory testing procedures. The concept of "ground truth" established by experts, as required for diagnostic devices (e.g., radiologists interpreting images), is not applicable here.
Instead, the "ground truth" for this type of device (Assayed Quality Control Material) is the assigned values for the analytes within the control. These are established through:
- Method: "replicate analyses"
- Personnel: Tests were "performed by the manufacturer and/or independent laboratories"
- Qualifications: While not explicitly detailed, these laboratories would employ trained personnel (e.g., clinical chemists, laboratory scientists) proficient in the analytical methods for each analyte.
4. Adjudication Method for the Test Set
Again, the concept of "adjudication" in the sense of resolving discrepancies among expert readers (e.g., 2+1, 3+1) is not applicable to this type of device. The "ground truth" (assigned values) is established through rigorous laboratory testing using replicate analyses, not through human interpretation of complex data that might require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI
No, an MRMC comparative effectiveness study was not done. This device is a quality control material, not a diagnostic imaging or screening tool that would involve AI assistance for human readers. Therefore, the effect size of AI improvement is not relevant or reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a biochemical control material, not an algorithm or AI system. Its performance is evaluated based on its stability and the accuracy of its assigned values when measured by laboratory instruments, not as a standalone algorithmic output.
7. The Type of Ground Truth Used
The ground truth used for this type of quality control device is the assigned values for the various analytes it contains. These values are established through:
- Expert Consensus / Reference Methods: While not explicitly stated as "expert consensus," the "replicate analyses" performed by the manufacturer and independent laboratories using "manufacturer supported reagents" are indicative of adherence to established, scientifically sound analytical methodologies that are considered the reference or "true" values for the analytes. The ±3SD ranges reported are statistical measures around this empirically determined true value.
8. The Sample Size for the Training Set
This document describes a quality control material, not a machine learning model. Therefore, the concept of a "training set" for an algorithm is not applicable. The device itself is the "product," and its stability and assigned values are characterized through direct experimentation.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" or "ground truth for a training set" in the context of this device. The "assigned values" for the control material are established through "replicate analyses" by the manufacturer and/or independent laboratories.
{0}------------------------------------------------
Page 1 of 3
Summary of Safety and Effectiveness Liquid Assayed Multiqual
SEP 1 4 2010
1.0 Submitter
. .
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:
Contact Person
Suzanne S. Parsons Regulatory Affairs Specialist (949) 598-1467 Telephone:
Date of Summary Preparation
September 10, 2010
2.0 Device Identification
| Product Trade Name: | Liquid Assayed Multiqual |
|---|---|
| Common Name: | Multi-Analyte Controls, (Assayed and unassayed) |
| Classifications: | Class I |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |
Device to Which Substantial Equivalence is Claimed 3.0
Liquid Assaved Multiqual Bio-Rad Laboratories Irvine, California
510 (k) Number: K043208
4.0 Description of Device
Liguid Assayed Multiqual is prepared from human serum to which purified biochemical material (tissue extracts of human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added.
5.0 Intended Use
Liquid Assayed Multiqual 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.
{1}------------------------------------------------
›
Page 2 of 3
6.0 Comparison of the new device with the Predicate Device
Liquid Assayed Multiqual claims substantial equivalence to the Liquid Assayed Multiqual currently in commercial distribution (K043208). Both of these controls are liquid human serum base with identical formulation. Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.
| Characteristics | |||||
|---|---|---|---|---|---|
| Bio-Rad LaboratoriesLiquid Assayed Multiqual(New Device) | Bio-Rad LaboratoriesLiquid Assayed Multiqual(Predicate Device K043208) | ||||
| Similarities | |||||
| Intended Use | Liquid Assayed Multiqual is intended for use as an assayed qualitycontrol serum to monitor the precision of laboratory testing procedures forthe analytes listed in this package insert. | Liquid Assayed Multiqual is intended for use as an assayed qualitycontrol serum to monitor the precision of laboratory testing procedures forthe analytes listed in this package insert. | |||
| Form | Liquid | Liquid | |||
| Matrix | Human serum based | Human serum based | |||
| Differences | |||||
| Storage (Unopened) | Until expiration date at -20°C to -50°C | Until expiration date at -20°C to -70°C | |||
| Thawed andUnopened Claim- | 30 days at 2 to 8°C, with the following exceptions: Direct Bilirubin 11days, Triglycerides, HDL, Cholinesterase, Phosphorus 7 days. TotalBilirubin and Direct Bilirubin values may decrease, Alkaline Phosphataseactivity may rise. | 30 days at 2 to 8°C, with the following exceptions: Direct Bilirubin 11days, Triglycerides, HDL, Phosphorus 7 days, Total Bilirubin and DirectBilirubin values may decrease, Alkaline Phosphatase activity may rise.The control must be stored frozen when using AST methods withoutpyridoxal-5-phosphate. | |||
| Thawed and OpenedClaim | 5 days at 2 to 8°C. Note: CO₂ values may gradually decrease on-boardthe Siemens Dimension Vista, following product sampling into the aliquotplate if allowed to stand for an extended time period. | 14 days at 2 to 8°C, with the following exception: Direct Bilirubin,Triglycerides, HDL, Phosphorus will be stable for 7 days, LAPArylamidase will be stable for 3 days. | |||
| Frozen Aliquot | None | AST/SGOT, Direct Bilirubin, HDL, Phosphorus, LDL, Triglycerides, LAPArylamidase: 14 days in amber vials at -20 to -70°C | |||
| Fill Volume | 2.5 mL | 3 mL | |||
| Analytes | Contains: | Contains: | |||
| AcetaminophenAlpha-1-AntitripsinApolipoprotein A-1Apolipoprotein BAlbuminAlkaline Phosphatase (ALP)ALT/SGPTAmylaseAST/SGOTBilirubin, DirectBilirubin, TotalC3 ComplementC4 ComplementCeruloplasminCalcium, TotalCarbamazepineCarbon Dioxide (CO2)ChlorideHDLLDLCholesterol, TotalPseudocholinesteraseCreatinineCreatine Kinase (CK)DigoxinEthanolFerritinGGTGentamicinGlucoseHaptoglobin | IronImmunoglobulin A (IgA)Immunoglobulin G (IgG)Immunoglobulin M (IgM)TIBCLactate (Lactic Acid)LDHLipaseLithiumMagnesiumPhenobarbitalPhenytoinPhosphorusPotassiumPrealbuminProtein, TotalSalicylateSodiumT3 TotalT3 Uptake/T-UptakeT4 TotalT4 FreeTheophyllineTSHTobramycinTransferrinTriglyceridesUric AcidValproic AcidVitamin B12 | AcetaminophenAlpha-1-AntitripsinαHBDHApolipoprotein A-1Apolipoprotein BAlkaline Phosphatase (ALP)ALT/SGPTAmikacinAmylaseAmylase, PancreaticAST/SGOTAcid PhosphataseAlbuminBilirubin, DirectBilirubin, NeonatalBilirubin, TotalC3 ComplementC4 ComplementCeruloplasminCholinesteraseCalcium, IonizedCopperCalcium, TotalCarbamazepineCarbon Dioxide (CO2)ChlorideHDLLDLCholesterol, TotalCK-MB IsoenzymeCortisolCreatinineCreatine Kinase (CK)FerritinEthanolDigoxinGGTGentamicinGlobulinGlucoseHaptoglobin | IronImmunoglobulin A (IgA)Immunoglobulin G (IgG)Immunoglobulin M (IgM)TIBCUIBCLactate (Lactic Acid)LDHLAP ArylamidaseLipaseLithiumMagnesiumOsmolalityPhenobarbitalPhenytoinPhospholipidsPhosphorusPotassiumPrealbuminPAPProtein ElectrophoresisProtein, TotalSalicylateSodiumT3 FreeT3 TotalT3 Uptake/T-UptakeT4 TotalT4 FreeTheophyllineTSHTobramycinTransferrinTriglyceridesUreaUrea Nitrogen (BUN)Uric AcidValproic AcidVitamin B12Zinc | ||
| Does Not Contain: | |||||
| αHBDHAmikacinAmylase, PancreaticAcid PhosphataseBilirubin, NeonatalCalcium, IonizedCopperCK-MB IsoenzymeCortisol | GlobulinUIBCLAP ArylamidaseOsmolalityPhospholipidsPAPProtein ElectrophoresisUreaZinc |
Table 1. Similarities and Differences between new and predicate device.
.
{2}------------------------------------------------
7.0 Statement of Supporting Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquid Assayed Multiqual. Product claims are as follows:
| 7.1 | Open vial 5 days at 2 to 8°C |
|---|---|
| 7.2 | Thawed and Unopened: 30 days at 2 to 8°C, with the following exceptions: Direct Bilirubin 11 days, Triglycerides, HDL, Cholinesterase, Phosphorus 7 days. Total Bilirubin and Direct Bilirubin values may decrease, Alkaline Phosphatase activity may rise. |
| 7.3 | Shelf Life Stability 3 Years at -20°C to -50°C |
- 7.4 Assignment of Values The assigned values were derived from replicate analyses and are specific for each lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of the product lot. Assigned values are presented as means and ±3SD ranges.
8.0 Conclusion
Liquid Assayed Multiqual (new device) is intended to be used for the same purposes as the predicate device, it has the same human serum matrix and performs similarly as the predicate device.
All supporting data is retained on file at Bio-Rad Laboratories.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
BEBARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 0903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Bio-Rad Diagnostics Group c/o Suzanne Parsons Regulatory Affairs/QA/QC Manager 9500 Jeronimo Road Irvine, CA 92618-2017, USA
SEP 1 4 2010
Re: K100727 Liquid Assayed Multiqual Trade/Device Name: Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: August 27, 2010 Received: September 3, 2010
Dear Ms. Parsons
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your Doctor Doctor Droppy of device is substantially equivalent (for the indications for relerenced above and have dolorinined marketed predicate devices marketed in interstate commerce use stated in the encround to regary thate of the Medical Device Amendments, or to devices that provide in May 20, 1976, the chaemism and the Rederal Food, Drug, and Cosmotic have been tectassified in accordance with a premarket approval application (PMA). You may, ACL (ACC) inal do not require approval or a presental controls provisions of the Act. The general therefore, market the device, subject to the genirements for annual registration, listing of devices, good Controls provisions of the beling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see above) into emaint regulations affecting your device can be may be subject to such additional controlls. Existing in as a sep. 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 Please be advised that FDA 's issualice of a substance or a substances with other requirement of the Act or
that FDA has made a determination that your device complies with o that FDA has made a decemination mar your correst correst agencies. You must comply
any Federal statutes and regulations administered by other and lights (21 CFP P any Federal Statutes and regulations administered by other to: registration and listing (2) CFR Pat
with all the Act's requirements, including, but not limited to: requiremen with all the Act STEquilements, melaams, our manufacturing practice requirements as set
807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirement forth in the quality systems (QS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin markemig your over and the same of your device to a legally premarket notification. The FDA midnig of succianted vice and thus, permits your device to proceed to the market.
{4}------------------------------------------------
Page 2 -
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 Diagnostic Device Evaluation and Safety 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/ReportalProblem/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,
G.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use Form
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use: Liquid Assayed Multiqual is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes list precision in this package insert.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100727
Page 1 of 1
§ 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.