(183 days)
Not Found
No
The summary describes a quality control serum for laboratory testing, with no mention of AI or ML technologies in the device description, intended use, or performance studies.
No
This device is a quality control serum used to monitor the precision of laboratory testing procedures, not to treat or diagnose patients.
No
The device is described as an "assayed quality control serum to monitor the precision of laboratory testing procedures," not to diagnose a patient's condition.
No
The device description explicitly states it is prepared from human serum and includes biochemical material, chemicals, drugs, preservatives, and stabilizers, 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 this package insert." This is a classic function of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description mentions it's prepared from "human serum" and contains added biochemical materials, chemicals, drugs, preservatives, and stabilizers. This composition is consistent with a control material used in laboratory testing of human samples.
- Intended User / Care Setting: The intended user is involved in "laboratory testing procedures," which is the environment where IVDs are used.
- Predicate Device: The mention of a predicate device (K043208; Liquid Assayed Multiqual) strongly suggests that this device is being compared to a previously cleared IVD, further indicating its classification as an IVD.
While the document doesn't mention image processing, AI, or specific performance metrics like sensitivity or specificity (which are more relevant for diagnostic tests themselves, not necessarily controls), the core function and composition clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
JJY
Device Description
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.
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
Stability studies have been performed to determine the open vial stability and shelf life for the Liquid Assayed Multiqual. Product claims are as follows:
- Open vial 5 days at 2 to 8 degrees C
- Thawed and Unopened: 30 days at 2 to 8 degrees 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.
- Shelf Life Stability 3 Years at -20 degrees C to -50 degrees C
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 plus minus 3SD ranges.
Key Metrics
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.
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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.
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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 Laboratories | |||||
| Liquid Assayed Multiqual | |||||
| (New Device) | Bio-Rad Laboratories | ||||
| Liquid Assayed Multiqual | |||||
| (Predicate Device K043208) | |||||
| Similarities | |||||
| 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. | 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. | |||||
| 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 and | |||||
| Unopened Claim- | 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. | 30 days at 2 to 8°C, with the following exceptions: Direct Bilirubin 11 | ||||
| days, Triglycerides, HDL, Phosphorus 7 days, Total Bilirubin and Direct | |||||
| Bilirubin values may decrease, Alkaline Phosphatase activity may rise. | |||||
| The control must be stored frozen when using AST methods without | |||||
| pyridoxal-5-phosphate. | |||||
| Thawed and Opened | |||||
| Claim | 5 days at 2 to 8°C. Note: CO₂ values may gradually decrease on-board | ||||
| the Siemens Dimension Vista, following product sampling into the aliquot | |||||
| plate 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, LAP | |||||
| Arylamidase will be stable for 3 days. | |||||
| Frozen Aliquot | None | AST/SGOT, Direct Bilirubin, HDL, Phosphorus, LDL, Triglycerides, LAP | |||
| Arylamidase: 14 days in amber vials at -20 to -70°C | |||||
| Fill Volume | 2.5 mL | 3 mL | |||
| Analytes | Contains: | Contains: | |||
| Acetaminophen | |||||
| Alpha-1-Antitripsin | |||||
| Apolipoprotein A-1 | |||||
| Apolipoprotein B | |||||
| Albumin | |||||
| Alkaline Phosphatase (ALP) | |||||
| ALT/SGPT | |||||
| Amylase | |||||
| AST/SGOT | |||||
| Bilirubin, Direct | |||||
| Bilirubin, Total | |||||
| C3 Complement | |||||
| C4 Complement | |||||
| Ceruloplasmin | |||||
| Calcium, Total | |||||
| Carbamazepine | |||||
| Carbon Dioxide (CO2) | |||||
| Chloride | |||||
| HDL | |||||
| LDL | |||||
| Cholesterol, Total | |||||
| Pseudocholinesterase | |||||
| Creatinine | |||||
| Creatine Kinase (CK) | |||||
| Digoxin | |||||
| Ethanol | |||||
| Ferritin | |||||
| GGT | |||||
| Gentamicin | |||||
| Glucose | |||||
| Haptoglobin | Iron | ||||
| Immunoglobulin A (IgA) | |||||
| Immunoglobulin G (IgG) | |||||
| Immunoglobulin M (IgM) | |||||
| TIBC | |||||
| Lactate (Lactic Acid) | |||||
| LDH | |||||
| Lipase | |||||
| Lithium | |||||
| Magnesium | |||||
| Phenobarbital | |||||
| Phenytoin | |||||
| Phosphorus | |||||
| Potassium | |||||
| Prealbumin | |||||
| Protein, Total | |||||
| Salicylate | |||||
| Sodium | |||||
| T3 Total | |||||
| T3 Uptake/T-Uptake | |||||
| T4 Total | |||||
| T4 Free | |||||
| Theophylline | |||||
| TSH | |||||
| Tobramycin | |||||
| Transferrin | |||||
| Triglycerides | |||||
| Uric Acid | |||||
| Valproic Acid | |||||
| Vitamin B12 | Acetaminophen | ||||
| Alpha-1-Antitripsin | |||||
| αHBDH | |||||
| Apolipoprotein A-1 | |||||
| Apolipoprotein B | |||||
| Alkaline Phosphatase (ALP) | |||||
| ALT/SGPT | |||||
| Amikacin | |||||
| Amylase | |||||
| Amylase, Pancreatic | |||||
| AST/SGOT | |||||
| Acid Phosphatase | |||||
| Albumin | |||||
| Bilirubin, Direct | |||||
| Bilirubin, Neonatal | |||||
| Bilirubin, Total | |||||
| C3 Complement | |||||
| C4 Complement | |||||
| Ceruloplasmin | |||||
| Cholinesterase | |||||
| Calcium, Ionized | |||||
| Copper | |||||
| Calcium, Total | |||||
| Carbamazepine | |||||
| Carbon Dioxide (CO2) | |||||
| Chloride | |||||
| HDL | |||||
| LDL | |||||
| Cholesterol, Total | |||||
| CK-MB Isoenzyme | |||||
| Cortisol | |||||
| Creatinine | |||||
| Creatine Kinase (CK) | |||||
| Ferritin | |||||
| Ethanol | |||||
| Digoxin | |||||
| GGT | |||||
| Gentamicin | |||||
| Globulin | |||||
| Glucose | |||||
| Haptoglobin | Iron | ||||
| Immunoglobulin A (IgA) | |||||
| Immunoglobulin G (IgG) | |||||
| Immunoglobulin M (IgM) | |||||
| TIBC | |||||
| UIBC | |||||
| Lactate (Lactic Acid) | |||||
| LDH | |||||
| LAP Arylamidase | |||||
| Lipase | |||||
| Lithium | |||||
| Magnesium | |||||
| Osmolality | |||||
| Phenobarbital | |||||
| Phenytoin | |||||
| Phospholipids | |||||
| Phosphorus | |||||
| Potassium | |||||
| Prealbumin | |||||
| PAP | |||||
| Protein Electrophoresis | |||||
| Protein, Total | |||||
| Salicylate | |||||
| Sodium | |||||
| T3 Free | |||||
| T3 Total | |||||
| T3 Uptake/T-Uptake | |||||
| T4 Total | |||||
| T4 Free | |||||
| Theophylline | |||||
| TSH | |||||
| Tobramycin | |||||
| Transferrin | |||||
| Triglycerides | |||||
| Urea | |||||
| Urea Nitrogen (BUN) | |||||
| Uric Acid | |||||
| Valproic Acid | |||||
| Vitamin B12 | |||||
| Zinc | |||||
| Does Not Contain: | |||||
| αHBDH | |||||
| Amikacin | |||||
| Amylase, Pancreatic | |||||
| Acid Phosphatase | |||||
| Bilirubin, Neonatal | |||||
| Calcium, Ionized | |||||
| Copper | |||||
| CK-MB Isoenzyme | |||||
| Cortisol | Globulin | ||||
| UIBC | |||||
| LAP Arylamidase | |||||
| Osmolality | |||||
| Phospholipids | |||||
| PAP | |||||
| Protein Electrophoresis | |||||
| Urea | |||||
| Zinc |
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.
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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
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