(37 days)
No
The summary describes a quality control serum product for laboratory testing, focusing on its composition and stability. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an "assayed quality control serum to monitor the precision of laboratory testing procedures," indicating it is used for quality control in diagnostics, not for treating a condition.
No
The device is a quality control serum used to monitor the precision of laboratory testing procedures, not to diagnose a patient's medical condition. It helps to ensure that diagnostic tests are performed accurately by the laboratory.
No
The device description explicitly states the product is prepared from human serum and provided in liquid form, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of laboratory testing procedures for the analytes listed in the package insert." This is a classic function of an in vitro diagnostic device used in a laboratory setting.
- Device Description: The description mentions it's prepared from human serum and contains biochemicals, chemicals, drugs, preservatives, and stabilizers. These are components typically found in IVD control materials.
- Intended User / Care Setting: The intended user is "laboratory testing procedures," which aligns with the use of IVDs in a laboratory environment.
While it's a quality control material and not a test that directly diagnoses a disease, quality control materials are considered IVDs because they are used in vitro (outside the body) to ensure the accuracy and reliability of diagnostic tests.
N/A
Intended Use / Indications for Use
Liquid Assayed Multiqual Premium 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.
Product codes
JJY
Device Description
This product is prepared from human serum to which purified biochemical (tissue extracts of human and animal origin), chemicals, drugs, preservatives and stabilizers have been added. The control is provided in liquid form for convenience.
Table 1: Product Catalog DescriptIon
| Description | Configuration |
|---|---|
| Liquid Assayed Multiqual Premium, Level 1 | 6 x 5 mL |
| Liquid Assayed Multiqual Premium, Level 2 | 6 x 5 mL |
| Liquid Assayed Multiqual Premium, Level 3 | 6 x 5 mL |
| Liquid Assayed Multiqual PremiumTrilevel MiniPak | 3 x 5 mL (1 per level) |
Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitls B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2. This product may also contain other human source material for which there are no approved tests. In accordance with good laboratory practice, all human source material should be considered potentially infectious and handled with the same precautions used with patient specimens.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Real Time Stability studies were conducted to establish thawed (opened and unopened vial) stability and frozen aliquot stability claims. Accelerated Stability studies were conducted to establish the shelf life stablity claims. Acceptance criteria were met to support product as claimed:
Thawed and Opened Vial Stability: All analytes will be stable for 14 days when stored tightly capped at 2 to 8℃, with the following exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days.
Thawed and Unopened Vial Stability: All analytes will be stable for 14 days when stored tightly capped at 2 to 8°C, with the following exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days.
Frozen Aliquot Stabillty: AST/SGOT, Direct Bilirubln, HDL, Phosphorus, LDL, and Triglycerides will be stable for 14 days when stored in tightly capped aliquot amber vials at -20 to -70°C.
Shelf life Stability: 3 Years at -20 to -70 ℃
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary Liquid Assayed Multiqual Premium
MAR 01 2013
1.0 Submitter
130162
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
February 26, 2013
2.0 Device Identification
| Product Trade Name: | Liquid Assayed Multiqual Premium |
|---|---|
| Common Name: | Multi-Analyte Controls, All Kinds (Assayed) |
| Classifications: | Class I, Reserved |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |
Device to Which Substantial Equlvalence is Claimed 3.0
| Predicate Device Information | |
|---|---|
| Device Name: | Liquid Assayed Multiqual |
| Applicant: | Bio-Rad Laboratories |
| 510(k) Number: | K100727 |
| Product Code: | JJY |
| Regulation #: | 862.1660 |
| Device Classification Name: | Multi-analyte Controls All Kinds(Assayed) |
1
???" 4.0 Description of Device
This product is prepared from human serum to which purified biochemical (tissue extracts of human and animal origin), chemicals, drugs, preservatives and stabilizers have been added. The control is provided in liquid form for convenience.
Table 1: Product Catalog DescriptIon
| Description | Configuration |
|---|---|
| Liquid Assayed Multiqual Premium, Level 1 | 6 x 5 mL |
| Liquid Assayed Multiqual Premium, Level 2 | 6 x 5 mL |
| Liquid Assayed Multiqual Premium, Level 3 | 6 x 5 mL |
| Liquid Assayed Multiqual PremiumTrilevel MiniPak | 3 x 5 mL |
| (1 per level) |
Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitls B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2. This product may also contain other human source material for which there are no approved tests. In accordance with good laboratory practice, all human source material should be considered potentially infectious and handled with the same precautions used with patient specimens.
5.0 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. Data from Unity™ Interlaboratory Program are included in the determination of some ranges. 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 guides. 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.
The data printed in our package insert meet our internal processes and procedure requirements for the assignment of values.
6.0 Intended Use
Liquid Assayed Multiqual Premium is intended for use as an assaved quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
2
Comparison of the new device with the Predicate Device 7.0
Liquid Assayed Multiqual Premium is substantially equivalent to Liquid Assayed Multiqual currently in commercial distribution under 510(k) K100727. Table 1 (below) indicates similarities and differences between the new and predicate device.
Table 1. Similarities and Differences between new and predicate device.
| Liquid Assayed Multiqual Premlum | Liquid Assayed Multiqual | |||||
|---|---|---|---|---|---|---|
| (New Device) | (Predicate Device - 510(k) cleared under K100727) | |||||
| Similarities | ||||||
| Intended Use | Liquid Assayed Multiqual Premium is intended for use as an | |||||
| assayed quality control serum to monitor the precision of | ||||||
| laboratory testing procedures for the analytes ilsted in the | ||||||
| package Insert. | Llould 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. | ||||||
| Matrix | Human Serum | Human Serum | ||||
| Form | Liquid | Liquid | ||||
| Differences | ||||||
| Analytes | Contains: | Contains: | ||||
| AcetamInophen | Haptoglobin | Acetaminophen | Immunoglobulin M (IgM) | |||
| Acid Phosphatase | İmmunoglobulin A (IgA) | Alanine Aminotransferase | ||||
| (ALT/SGPT) | lron | |||||
| Alanine | ||||||
| AmInotransferase(ALT/SGPT) | Immunoglobulin G (IgG) | AlbumIn | Iron Binding Capacity, Total | |||
| (TIBC) | ||||||
| Albumin | Immunoglobulln M (IgM) | Alkaline Phosphatase (ALP) | Lactate (Lactic Add) | |||
| Alkaline Phosphatase (ALP) | lron | Alpha-1-Antitrypsin | Lactate Dehydrogenase | |||
| (LDH) | ||||||
| Alpha-1-Acld Glycoprotein | Iron Binding Capacity, | |||||
| Total (TIBC) | Amylase | Lipase | ||||
| Alpha-1-Antitrypsin | Iron Binding Capacity, | |||||
| Unsaturated (UIBC) | Apollpoproteln A-1 | Lithlum | ||||
| Alpha-Hydroxybutyrate | ||||||
| Dehydrogenase (aHBDH) | Kappa Light Chalns | Apolipoprotein B | Magnesium | |||
| Amikacin | Lactate (Lactic Acid) | Aspartate Aminotransferase | ||||
| (AST/SGOT) | Phenobarbital | |||||
| Amylase | Lactate Dehydrogenase | |||||
| (LDH) | Bilirubin, Direct | Phenytoln | ||||
| Amylase, Pancreatic | Lambda Light Chains | Bilirubin, Total | Phosphorus | |||
| Antl-CCP | Lidocaine | C3 Complement | Potasslum | |||
| Apollpoprotein A-1 | Lipase | C4 Complement | Prealbumin | |||
| Apolipoproteln B | Lithlum | Calclum, Total | Proteln, Total | |||
| ASO | Magneslum | Carbamazepine | Sallcylate | |||
| Aspartate Aminotransferase | ||||||
| (AST/SGOT) | Methotrexate | Carbon Dioxide (CO2) | Sodlum | |||
| Beta-2-Microglobulin | NAPA | Ceruloplasmin | T3 Total | |||
| Bile Acids | ||||||
| Billrubin, Direct | Osmolality | Chloride | T3 Uptake/T-Uptake | |||
| Phenobarbital | Cholesterol, High Density | |||||
| Lipoprotein (HDL) | T4 Free | |||||
| Billrubin, Total | Phenytoin | Cholesterol, Low Density | ||||
| Lipoprotein (LDL) | T4 Total | |||||
| Bilirubin, Neonatal | Protein Electrophoresis | Cholesterol, Total | Theophylline | |||
| C3 Complement | Phosphollplds | Creatine Kinase (CK) | Thyroid Stimulating Hormone | |||
| (TSH) | ||||||
| C4 Complement | Phosphorus | Creatinine | Tobramycin | |||
| Caffeine | Potasslum | Digoxin | Transferrin | |||
| Calcium, Ionized | Prealbumin | Ethanol | Triglycerides | |||
| Calcium. Total | Procalnamide | Ferritin | Urea Nitrogen (BUN) | |||
| Carbamazepine | Proteln, Total | Gamma Glutamyltransferase | ||||
| (GGT) | Uric Acid |
3
| Carbon Dioxide (CO2) | Glucose | Gentamicin | Valproic Acid | |
|---|---|---|---|---|
| Ceruloplasmin | Quinidine | Glucose | Vitamin B12 | |
| Chloride | Salicylate | Haptoglobin | Pseudocholinesterase | |
| Cholesterol, High Density | Sodium | Immunoglobulin A (IgA) | ||
| Lipoprotein (HDL) | ||||
| Cholesterol, Low Density | T3 Total | Immunoglobulin G (IgG) | ||
| Lipoprotein (LDL) | ||||
| Cholesterol, Total | T3 Uptake/T-Uptake | |||
| Cholinesterase | T4 Free | Does not contain: | ||
| Copper | T4 Total | Acid Phosphatase | Iron Binding Capacity, | |
| Unsaturated (UIBC) | ||||
| Cortisol | Theophylline | Alpha-1-Acid Glycoprotein | Kappa Light Chains | |
| Creatine Kinase (CK) | Thyroid Stimulating | |||
| Hormone (TSH) | Alpha-Hydroxybutyrate | |||
| Dehydrogenase (aHBDH) | Lambda Light Chains | |||
| Creatinine | Tobramycin | Amikacin | Lidocaine | |
| CRP | Transferrin | Amylase, Pancreatic | Methotrexate | |
| Cystatin C | Triglycerides | Anti-CCP | NAPA | |
| Digoxin | Urea | ASO | Osmolality | |
| Disopyramide | Urea Nitrogen (BUN) | Beta-2-Microglobulin | Phospholipids | |
| Ethanol | Uric Acid | Bile Acids | Procainamide | |
| Ferritin | Valproic Acid | Bilirubin, Neonatal | Protein Electrophoresis | |
| Gamma Glutamyltransferase | ||||
| (GGT) | Vancomycin | Caffeine | Quinidine | |
| Gentamicin | Vitamin B12 | Calcium, Ionized | Triglycerides | |
| Globulin | Zinc | CRP | Urea | |
| Does not contain: | Cystatin C | Uric Acid | ||
| Pseudocholinesterase | Globulin | Vancomycin | ||
| Shelf Storage | ||||
| Stability | Until expiration date at -20 to -70 °C | Until expiration date at -20 to -50 °C | ||
| Thawed & | ||||
| Unopened Vial | ||||
| Stability | When the control material Is thawed and stored unopened at | |||
| 2 to 8°C, all analytes will be stable for 30 days with the | ||||
| following exceptions: Direct Bilirubin will be stable for 11 | ||||
| days, Triglycerides, HDL, Cholinesterase, and Phosphorus | ||||
| will be stable for 7 days. | When this product is stored at 2 to 8°C unopened and the | |||
| stopper is not punctured, all analytes will be stable for 30 days | ||||
| with the following exceptions: Direct Bilirubin will be stable for | ||||
| 11 days, Triglycerides, HDL, Pseudocholinesterase and | ||||
| Phosphorus will be stable for 7 days. This product can be used | ||||
| for 7 days when stored on-board the Siemens Dimension Vista | ||||
| at 2 to 8°C, | ||||
| Thawed and | ||||
| Opened Vial | ||||
| Stability | Once the control material Is thawed and opened, all analytes | |||
| will be stable for 14 days when stored tightly capped at 2 to | ||||
| 8°C, with the following exceptions: Direct Bilirubin, | ||||
| Triglycerides, HDL, Cholinesterase, and Phosphorus will be | ||||
| stable for 7 days. | Once the product stopper is punctured, all analytes will be | |||
| stable for 5 days when stored at 2 to 8°C. | ||||
| Frozen Aliquot | ||||
| Stability | AST/SGOT, Direct Bilirubin, HDL, Phosphorus, LDL, and | |||
| Triglycerides will be stable for 14 days when stored in tightly | ||||
| capped aliquot amber vials at -20 to -70°C. | No claims made. | |||
| Fill Size | 5 mL | 2.5 mL | ||
8.0 Statement of Supporting Data
Real Time Stability studies were conducted to establish thawed (opened and unopened vial) stability and frozen aliquot stability claims. Accelerated Stability studies were conducted to establish the shelf life stablity claims. Acceptance criteria were met to support product as claimed:
・
Thawed and Opened Vial Stability: All analytes will be stable for 14 days when stored tightly capped at 2 to 8℃, with the following exceptions: Direct Bilirubin, Triglycerides, HDL,
4
Cholinesterase, and Phosphorus will be stable for 7 days.
stored in tightly capped aliquot amber vials at -20 to
- Thawed and Unopened Vial Stability: All analytes will be stable for 14 days when stored tightly capped at 2 to 8°C, with the following exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days. Frozen Aliquot Stabillty: AST/SGOT, Direct Bilirubln, HDL, Phosphorus, LDL, and Triglycerides will be stable for 14 days when
-70°C.
Shelf life Stability: 3 Years at -20 to -70 ℃
9.0 Conclusion
Based on the performance characteristics indicated above, Liquid Assayed Multiqual i Premium Control is substantially equivalent to the predicate device.
All supporting data is retained on file at Bio-Rad Laboratories.
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5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 1, 2013
Bio-Rad Laboratories c/o Suzanne Parsons 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K130162
Trade/Device Name: Liquid Assayed Multiqual Premium Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material Regulatory Class: Class I, Reserved Product Code: JJY Dated: January 21, 2013 Received: January 23, 2013
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
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
S FDA
Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Devices · Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K130162
Device Name: Liquid Assayed Multiqual Premium
Indications for Use:
Liquid Assayed Multiqual Premium 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.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
YungWDChan-S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K130162 510(k)_