(28 days)
Liquid Assayed Multiqual® Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.
Liquid Assayed Multiqual® Control 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 control is provided in liquid form for convenience.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Bio-Rad Laboratories Liquid Assayed Multiqual Control:
This document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results for novel device functions. Therefore, much of the requested information regarding detailed study design (like sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not explicitly available in this summary. The provided text primarily discusses stability studies to support product claims.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here refer to the stability claims for the control material. The reported device performance is presented as the stability duration for various storage conditions.
| Acceptance Criteria (Claimed Stability) | Reported Device Performance (Achieved Stability) |
|---|---|
| Open Vial Stability: | |
| - General analytes: 14 days at 2-8°C | 14 days at 2-8°C (tightly capped) |
| - Total bilirubin: 10 days at 2-8°C | 10 days at 2-8°C |
| - LAP Arylamidase: 3 days at 2-8°C | 3 days at 2-8°C |
| Closed Vial Stability (Thawed): | |
| - General analytes: 30 days at 2-8°C | 30 days at 2-8°C (stored unopened) |
| - Total bilirubin values: may decrease | Values may decrease |
| - Alkaline Phosphatase activity: may rise | Activity may rise |
| - AST methods without pyridoxal-5-phosphate: must be stored frozen | Must be stored frozen |
| Shelf Life (Closed Vial, Frozen): | |
| - 3 years at -20°C or colder | 3 years at -20°C or colder |
Regarding the Study Information:
Since this is a 510(k) summary for a control material, the "study" referred to is primarily stability testing rather than a clinical effectiveness study. The intent is to demonstrate that the control material maintains its integrity and stability under specified conditions for its intended use, which is "to monitor the precision of laboratory testing procedures."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified in the provided summary. "Real time studies will be ongoing to support the shelf life of this product" suggests a prospective component, but the summary primarily describes historical data that has already been collected. The studies were performed by Bio-Rad Laboratories, located in Irvine, California, USA, so presumably the data originates there.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. For a quality control material, the "ground truth" for stability is typically determined by analytical testing methods and comparison to initial formulated values, not expert consensus as in a diagnostic imaging study.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Stability studies rely on laboratory measurements and statistical analysis, not expert adjudication.
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
- MRMC Study: No, this is not applicable. This device is a liquid assayed control material, not an AI or diagnostic imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For stability studies of control materials, the "ground truth" is typically the initial analytical values of the components within the control at the time of manufacture, and then subsequent measurements are compared against these initial values to determine if they remain within acceptable ranges over time and under various storage conditions. This is based on analytical testing and established analytical methods, not expert consensus or pathology.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no "training set" as this is not an AI or machine learning device. The studies are related to the stability of the manufactured product.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
{0}------------------------------------------------
Bio-Rad Laboratories
Premarket Notification Section 510(k) for Liquid Assayed Multiqual Control
Summary of Safety and Effectiveness
KOII867
Page 1 of 3
Summary of Safety and Effectiveness Liquid Assayed Multiqual® Control Levels 1, 2 and 3
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax:
Contact Person
Ofelia Cachola Regulatory Affairs Specialist Telephone: (949) 598-1287
Date of Summary Preparation
June 8, 2001
2.0 Device Identification
Liquid Assayed Multiqual® Control Levels 1, 2 and 3 Product Trade Name: Multi-Analyte Controls, (Assayed and unassayed) Common Name:
Classifications: Class I 75JJY Product Code: CFR 862.1660 Regulation Number:
3.0 Device to Which Substantial Equivalence is Claimed
MULTIQUAL® ASY I, II, III Ciba Corning Diagnostics Corp. (Bio-Rad Laboratories) Irvine, California
Docket Number: K923633
4.0 Description of Device
Liquid Assayed Multiqual® Control 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 control is provided in liquid form for convenience.
{1}------------------------------------------------
Statement of Intended Use 5.0
Liquid Assayed Multiqual® Control is intended for use as an assayed quality Elquia Aseayou manifar the precision of laboratory testing procedures for analytes listed in the package insert.
Comparison of the new device with the Predicate Device 6.0
The new Liquid Assayed Multiqual® Control claims substantial equivalence to the MULTIQUAL ASY I, II, III (K923633).
| Bio Rad | Bio Rad | |
|---|---|---|
| Characteristics | Liquid Assayed Multiqual® ControlLevels 1, 2 and 3(New Device) | Liquid Assayed Multiqual® ControlLevels 1, 2 and 3(Predicate Device) |
| Similarities | ||
| Intended Use | Liquid Assayed Multiqual® Control isintended for use as an assayed qualitycontrol serum to monitor the precision oflaboratory testing procedures for theanalytes listed in the package insert. | Use Multiqual® quality control material,assayed, to monitor the precision and theaccuracy of general chemistry,immunochemistry, and therapeutic drugmonitoring test procedures. |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Storage(Unopened Frozen) | -20°C or colderuntil expiration date | Below -10 °Cuntil expiration date |
| Storage(Unopened Thawed) | 2-8° C30 days with the following exceptions:Total bilirubin values may decrease.Alkaline phosphatase activity may rise.The control must be stored frozen whenusing AST methods without pyridoxal-5-phosphate. | 2-8° C30 days with the following exceptions:Total bilirubin values may decrease.Alkaline phosphatase activity may rise.The control must be stored frozen whenusing AST methods without pyridoxal-5-phosphate. |
| Differences | ||
| Open, VialClaim | 2-8° C for 14 days with the followingexceptions: Total bilirubin will be stablefor 10 days and LAP Arylamidase will bestable for 3 days. | 2-8° C for 14 days with the followingexceptions: Total bilirubin will be stable for10 days. |
| Analytes | Same analytes as the predicate devicewith additional claims for the following:Acetaminophen, Alpha-1-Antitrypsin,Amikacin, Amylase (Pancreatic),Apolipoprotein A, Apolipoprotein B, C3Complement, C4 Complement,Ceruloplasmin, Cholesterol-LDL, CK-MBIsoenzyme, Copper, Globulin, | Refer to the substantially equivalentproduct insert. |
| Haptoglobin, Immunoglobulins (IgA, IgG,IgM), LAP-Arylamidase, Prealbumin,Prostatic Acid Phosphatase, ProteinElectrophoresis and Transferrin. | ||
Table 1. Similarities and Differences between new and predicate device.
06_SSE_Mult_9816_6/0
{2}------------------------------------------------
Summary of Performance Data 7.0
Stability studies have been performed to determine the open vial stability and shelf life for the Liquid Assayed Multiqual® Control. Product claims are as follows:
- Open vial: Once the control material is thawed and opened, all analytes 7.1 . will be stable for 14 days when stored tightly capped at 2-8℃ with the following exceptions: Total bilirubin will be stable for 10 days and LAP Arvlamidase will be stable for 3 days. Avoid repeated freezing and thawing of the quality control material.
- Closed vial: When the control material is thawed and stored unopened at 7.2 2-8°C, all analytes will be stable for 30 days 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.
- Shelf life: Three years when stored at -20°C or colder. For optimum 7.3 performance, avoid storage in a frost-free freezer. Store vials away from the light.
Real time studies will be ongoing to support the shelf life of this product.
All supporting data is retained on file at Bio-Rad Laboratories.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three overlapping wing shapes, suggesting movement or flight. The text is arranged so that "DEPARTMENT OF HEALTH & HUMAN SERVICES" is on the left side of the circle, and "USA" is on the right side.
ງປະ 1 2 2001
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Donna Chapman Quality Assurance/Regulatory Affairs Manager Bio Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618-2017
Re:
510(k) Number: K011867 STO(R) Name: Liquid Assayed Multiqual® Control Levels 1, 2, and 3 Regulation Number: 862.1660 Regulatory Class: I, reserved Product Code: JJY Dated: June 8, 2001 Received: June 14, 2001
Dear Ms. Chapman:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your books, be device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device microute conmistor proc to has been reclassified in accordance with the provisions of the Amendinoms, of to devices and in t (Act). You may, therefore, market the device, subject to I coord i ood, Drug, and Coomistic Fre Act. The general controls provisions of the Act include the general connois provisions of and isting 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remance ripproval), it may of success the Code of Federal Regulations, Title 21, Parts 800 to 895. atiount four as novelvalent determination assumes compliance with the Good Manufacturing A substantially oqurvalences and (GMP) regulation (21 CFR Part 820) and that, through I ractive for Mourself ons, the Food and Drug Administration (FDA) will verify such periodic GMP inspocals.comply with the GMP regulation may result in regulatory action. In assumptions: Transity to compty with in the mouncements concerning your device in the Federal adultion, I Dri may publish caranse to your premarket notification submission does not affect Any obligation you might have under sections 531 through 542 of the Act for devices under the any obtigation you mighting Control provisions, or other Federal laws or regulations.
{4}------------------------------------------------
This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will allow you to begin marketing our device of your device to a legally marketed
notification. The FDA finding of substantial equivals and thus, neemits your de notification. The FDA inding of substantar equiration of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the office of additionally 809.10 for in Vito diaguosic as nothe promotion and advertising of your device, (301) 594-4588. Additionally, for questions of (301) 594-4639. Also, please note the regulation please contact the Office of Compliation at (301) 37 Teation" (21CFR 807.97). Other general entitled, "Misbranding by telefence to plemanter the Act may be obtained from the Division of Small
information on your responsibilities under the Act (201) M3, 6597 or st it information on your responsibilities miser (800) 638-2041 or (301) 443-6597 or at its
Manufacturers Assistance at its toll-free humansing transman tran't Manufacturers Assistance at ta ton areas - 12 ton = 7 / 4 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________
Liquid Assayed Multiqual® Control Levels 1, 2 and 3 Device Name:
Indications for Use:
An assayed quality control serum to monitor the precision of laboratory
the first and the control to the diving his neekege insort An assayed quality outdres for analytes listed in the package insert.
Sean Cooper
(Division Sign-Off) y Devices Division of Clinical Laborator ﺎ ﺍ 510(k) Number
(Please DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
or Prescription use_
Over-the Counter use_
§ 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.