(22 days)
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No
The document describes a quality control material for laboratory testing and does not mention any AI or ML components.
No
Explanation: This device is a quality control material used to monitor the precision of laboratory testing procedures, not to treat or diagnose patients.
No
This device is a quality control material used to monitor the precision of laboratory testing procedures, not to diagnose a patient's medical condition. It ensures the accuracy of diagnostic tests.
No
The device is a physical control material (lyophilized human whole blood) and not a software-only medical device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly 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 IVD, specifically a quality control material used in laboratory testing.
- Device Description: It's a "quality control material" prepared from human whole blood, intended for use in a laboratory setting.
- Intended User / Care Setting: It's intended for use in a "laboratory."
- Predicate Device: The mention of a predicate device (K980871; Lyphochek® Whole Blood Control) strongly suggests it's being compared to a previously cleared IVD.
While the document doesn't explicitly use the term "IVD," all the characteristics and intended use align perfectly with the definition of an In Vitro Diagnostic device. It's a reagent or material used in a laboratory to perform tests on biological samples (in this case, to monitor the accuracy of tests performed on whole blood).
N/A
Intended Use / Indications for Use
Lyphochek® Whole Blood Control is intended for use as an assayed quality control material to monitor the precision of laboratory analytes listed in the package insert.
Product codes
JJY
Device Description
Lyphochek® Whole Blood Control is prepared from human whole blood, with pure chemicals, and stabilizers added. The control is provided in lyophilized form for increased stability.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability studies have been performed to determine the reconstituted stability and shelf life for the Lyphochek® Whole Blood Control. Product claims are as follows:
- 7.1 Reconstituted Stability: Once the control material is reconstituted, all analytes will be stable for 14 days at 2℃ to 8 ℃ with the following the exception: Red Cell Folate will be stable for 3 days at 2°C to 8°C.
- 7.2 Shelf Life: Three years and three months when stored at 2 to 8 °C
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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102204/
JUL 1 6 2002 Bio-Rad Laboratories Premarket Notification Section 510(k) for Lyphochek Whole Blood Control Summary of Safety and Effectiveness
Page 1 of 2
Summary of Safety and Effectiveness Lyphochek® Whole Blood Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1555
Contact Person
Maria Zeballos Regulatory Affairs Specialist (949) 598-1367 Telephone:
Date of Summary Preparation
June 18, 2002
2.0 Device Identification
| Product Trade Name: | Lyphochek® Whole Blood Control |
|---|---|
| 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
Lyphochek® Whole Blood Control Bio-Rad Laboratories Irvine, California
Docket Number: K980871
4.0 Description of Device
Lyphochek® Whole Blood Control is prepared from human whole blood, with pure chemicals, and stabilizers added. The control is provided in lyophilized form for increased stability.
5.0 Statement of Intended Use
Lyphochek® Whole Blood Control are intended for use as an assayed quality control material to monitor the precision of laboratory analytes listed in the package insert.
1
6.0 Comparison of the new device with the Predicate Device
Lyphochek® Whole Blood Control claims substantial equivalence to the Lyphochek® Whole Blood Control currently in commercial distribution (K980871). The new Lyphochek® Whole Blood Control contains Sirolimus and the current product does not.
| Characteristics | Bio Rad
Lyphochek® Whole Blood Control
(New Device) | Bio Rad
Lyphochek® Whole Blood Control
(Predicate Device) |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| Intended Use | Lyphochek® Whole Blood Control is intended for
use as an assayed quality control material to
monitor the precision of laboratory testing
procedures for the analytes listed in the package
insert. | Lyphochek® Whole Blood Control is intended for
use as an assayed quality control material to
monitor the precision of laboratory testing
procedures for the analytes listed in the package
insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Processed Human Whole Blood Lysate | Processed Human Whole Blood Lysate |
| | Differences | |
| Storage
(Unopened) | 2-8°C
until expiration date | 2-8°C
until expiration date |
| Reconstituted
Vial Claim | 14 days at 2°C to 8 °C
Exception: Red cell folate will be stable for 3
days at 2°C to 8°C. | 14 days at 2°C to 8 °C
Exception: Red cell folate will be stable for 3 days
at 2°C to 8°C. |
| After
reconstituting
and freezing | After reconstituting and freezing the control, all
analytes will be stable for 30 days when stored
tightly capped at -10 to -20°C. | After reconstituting and freezing the control, all
analytes will be stable for 30 days when stored
tightly capped at -10 to -20°C. |
| Analytes | Contains: Cyclosporine, Lead, Red Cell Folate,
Tacrolimus and Sirolimus. | Contains: Cyclosporine, Lead, Red Cell Folate,
Tacrolimus
Does not Contain: Sirolimus |
Table 1, Similarities and Differences hetween new and predicate device
7.0 Summary of Performance Data
Stability studies have been performed to determine the reconstituted stability and shelf life for the Lyphochek® Whole Blood Control. Product claims are as follows:
- 7.1 Reconstituted Stability: Once the control material is reconstituted, all analytes will be stable for 14 days at 2℃ to 8 ℃ with the following the exception: Red Cell Folate will be stable for 3 days at 2°C to 8°C.
- 7.2 Shelf Life: Three years and three months when stored at 2 to 8 °C
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.
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Food and Drug Administration 2098 Gaither Road ي ينهنجي ويوري ويورووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووو Rockville MD 20850
リリー 1 6 2002
Ms. Elizabeth Platt Regulatory Affairs/Quality Assurance Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618
Re: K022041 Trade/Device Name: Lyphochek® Whole Blood Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: June 18, 2002 Received: June 24, 2002
Dear Ms. Platt:
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 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); 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.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact.the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/odrb/dsma/dsmamain.html".
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
Page 2 -- 18 -- 1 -- 1
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510 (k) Number (if known):
Lyphochek® Whole Blood Control Device Name: Indications for Use:
Lyphochek® Whole Blood Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ Prescription use______________________________________________________________________________________________________________________________________________________________
Over-the Counter use_
Olan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. KO22041