(49 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.
The provided documentation describes the Liquid Assayed Multiqual device, a quality control serum. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes for test/training sets, expert involvement, or adjudication methods in the way typically expected for a diagnostic or AI-driven device.
This document is a Summary of Safety and Effectiveness (part of a 510(k) submission) for a quality control material. Its primary purpose is to establish substantial equivalence to a predicate device, not to present a detailed performance study with discrete acceptance criteria for a diagnostic tool.
Therefore, many of the requested items cannot be extracted from this document. Here's a breakdown of what can be inferred or directly stated, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit "acceptance criteria" are stated in the document in terms of performance metrics (e.g., sensitivity, specificity, accuracy, precision ranges for analytes). The document focuses on demonstrating that the new device is substantially equivalent to a predicate by having similar intended use, form, matrix, storage conditions, and open vial claims, with the primary difference being the addition of Lactic Acid as an analyte.
The "performance" reported is primarily related to stability:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Open Vial Stability | 14 days at 2 to 8°C (LAP Arylamidase stable for 3 days) |
| Thawed and Unopened Stability | 30 days at 2 to 8°C (with exceptions for Total Bilirubin and Alkaline Phosphatase) |
| Shelf Life Stability | 3 Years at -20°C or colder |
Explanation: The "acceptance criteria" here are implied by the stability claims made for the device. The study demonstrating these is referred to generally as "Stability studies."
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document refers to "Stability studies" but does not detail the number of samples or batches used for these studies.
- Data Provenance: Not specified. The country of origin for the data or whether it was retrospective or prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a quality control material, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for a quality control material is its chemical stability and stated analyte values, which are determined through laboratory testing procedures, not expert consensus.
4. Adjudication method for the test set
Not applicable. See point 3.
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 is not an AI-driven or diagnostic device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a quality control device like this would be the analytically determined values and stability characteristics of the biochemical components within the control material, established through validated laboratory methods. It's based on chemical and physical testing rather than clinical outcomes or expert interpretation of images/data.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Summary of the Study:
The document states that "Stability studies have been performed to determine the open vial stability and shelf life for the Liquid Assayed Multiqual." These studies resulted in the product claims listed under section 7.0 and 7.1, 7.2, and 7.3. The type of study conducted was a stability study to determine how long the control material retains its specified characteristics under various conditions (open vial, thawed and unopened, and frozen shelf life). All supporting data is stated to be "retained on file at Bio-Rad Laboratories."
Without access to those detailed studies, further specifics on methodology, sample sizes, or exact performance data beyond the claims made cannot be provided from this public summary.
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Summary of Safety and Effectiveness Liquid Assayed Multiqual
JAN - 7 2005
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
November 16, 2004
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 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquid Assayed Multiqual Bio-Rad Laboratories Irvine, California
510 (k) Number: K011867
4.0 Description of Device
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.
. . . . . . . . . .
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 the package insert.
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Comparison of the new device with the Predicate Device 6.0
Liquid Assayed Multiqual claims substantial equivalence to the Liquid Assayed Multiqual currently in commercial distribution (K011867). Both of these are liquid, human serum based controls. The new Liquid Assayed Multiqual contains the same analytes as the predicate device with the addition of Lactic Acid.
| Characteristics | Bio-Rad LaboratoriesLiquid Assayed Multiqual Control(New Device) | Bio-Rad LaboratoriesLiquid Assayed Multiqual Control(Predicate Device K011867) | ||
|---|---|---|---|---|
| Similarities | ||||
| Intended Use | Liquid Assayed Multiqual is intended for use as an assayedquality control serum to monitor the precision of laboratorytesting procedures for the analytes listed in this package insert. | Liquid Assayed Multiqual is intended for use as an assayedquality control serum to monitor the precision of laboratorytesting procedures for the analytes listed in this package insert. | ||
| Form | Liquid | Liquid | ||
| Matrix | Human serum based | Human serum based | ||
| Storage (Unopened) | -20°C or colder Until expiration date | -20°C or colder Until expiration date | ||
| Open Vial Claim | 14 days at 2 to 8°C, with the following exception: LAPArylamidase will be stable for 3 days. | 14 days at 2 to 8°C, with the following exception: LAPArylamidase will be stable for 3 days. | ||
| Differences | ||||
| Analytes | Contains: | Contains:Same analytes as the new device with the exception of Lactic Acid. | ||
| 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)FerritinEthanolDigoxinGGTGentamicinGlobulinGlucose | 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 |
Table 1. Similarities and Differences between new and predicate device.
:
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Statement of Supporting Data 7.0
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 | 14 days at 2 to 8°C, with the following exception: LAP Arylamidase will be stable for 3 days. |
|---|---|---|
| 7.2 | Thawed and Unopened: | 30 days at 2 to 8°C, with the following exceptions: Total Bilirubin values may decrease, Alkaline Phosphatase activity may rise. The control must be stored frozen when using AST methods without pyridoxal-5-phosphate. |
| 7.3 | Shelf Life Stability | 3 Years at -20°C or colder |
・・・・・
All supporting data is retained on file at Bio-Rad Laboratories.
・・・・・・
・・・・・
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DEPARTMENT OF HEALTH & HUMAN 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 stylized eagle or bird symbol, composed of three curved lines that suggest the shape of a bird's head and neck. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 7 2005
Ms. Maria Zeballos Regulatory Affairs Specialist Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K043208
Trade/Device Name: Liquid Assayed Multiqual Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: November 16, 2004 Received: November 19, 2004
Dear Ms. Zeballos:
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 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) rms lotet notification. The FDA finding of substantial equivalence of your device to a legally preshand nedicate 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. 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 Division 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/industry/support/index.html
Sincerely yours,
Carelia B. Looks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
510(k) Number (if known): K043208
Device Name:
Liquid Assayed Multiqual
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 listed in this package insert.
Prescription Use X (Part 21 CFR 801 Subpart D) · AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
acting
Office of In Vitro Diagnostic Device Evaluation and S
510(k) KD43208
Page 1 of
§ 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.