(55 days)
510K 992939
Not Found
No
The summary describes a quality control material for immunoassay tests, which is a chemical reagent, not a software or hardware device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is a quality control material used to monitor the performance of immunoassay test procedures, not to treat a medical condition.
No
Explanation: The device is a quality control material used to monitor the performance of immunoassay test procedures, not to diagnose a patient's condition directly.
No
The device is a lyophilized human serum based assayed quality control material, which is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and therapeutic drugs". This clearly indicates that the device is used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description mentions it's a "lyophilized human serum based assayed quality control material". Quality control materials are a common type of IVD used to ensure the accuracy and reliability of diagnostic tests.
- Predicate Device: The mention of a predicate device with a 510(k) number (992939) further supports its classification as a medical device, and given its intended use, specifically an IVD.
The lack of information regarding image processing, AI/ML, anatomical site, patient age, user/setting, and performance studies is typical for a quality control material, as its primary function is to validate the performance of other IVD tests, not to directly diagnose or treat patients.
N/A
Intended Use / Indications for Use
IMMUNOASSAY PLUS CONTROL is a lyophilized human serum based assayed quality control material intended to monitor the performance of serum immunoassay test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert.
IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and theraputic drugs as listed in this package insert.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
IMMUNOASSAY PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert. Human origin components are added to a human serum based matrix.
The product contains 0.1% sodium azide.
IMMUNOASSAY PLUS CONTROL will be offered in three levels of 5.0 mL filled vials.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
QUALITROL IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3 (510K 992939)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Product Performance and Substantial Equivalency
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: 1000237
MAR 1 9 2002
January 21, 2002
- Consolidated Technologies Submitter: 4401 Freidrich Lane Building 1, Suite 100 Austin, TX 78744 Phone: (512) 445-5100 (512) 445-5515 Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax:
Contact: Preparation date: Candice Betz
Product name (trade & common):
| Proprietary: | IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3 |
|---|---|
| Common: | Ligand Plus, Level 1,2, and 3 |
- MAS Immunoassay (IAC) Control, Levels 1,2, and 3 Also sold as: ICN Immunology 1,2
Classification name:
Class I Product code: JJY
21 CFR 862:1660: Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
Predicate device:
QUALITROL IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3 (510K 992939)
Device description:
IMMUNOASSAY PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert. Human origin components are added to a human serum based matrix.
The product contains 0.1% sodium azide.
IMMUNOASSAY PLUS CONTROL will be offered in three levels of 5.0 mL filled vials.
Intended use:
IMMUNOASSAY PLUS CONTROL is a lyophilized human serum based assayed quality control material intended to monitor the performance of serum immunoassay test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert.
Labeling: Immunoassay Plus Control is sold labeled and unlabeled.
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Product Performance and Substantial Equivalency
510(k) Summary (continued)
Comparative analysis:
The table below provides a summary of the technological characteristics between IMMUNOASSAY PLUS CONTROL and the predicate device.
| Device
Characteristic | IMMUNOASSAY PLUS
CONTROL | QUALITROL IMMUNOASSAY PLUS
CONTROL |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Assayed quality control serum for
monitoring performance of serum
immunoassay and therapeutic drug
test procedures. | Assayed quality control serum for
monitoring performance of serum
immunoassay and therapeutic druq
test procedures. |
| Matrix | Human Serum | Human Serum |
| Form | Lyophilized | Lyophilized |
| Vial | 5 mL glass | 5 mL glass |
| Analytes | 59 analytes of clinical significance
that may be found in serum. | 68 analytes of clinical significance
that may be found in serum. |
| Storage | 2-8°C | 2-8°C |
| Stability | Until expiration date noted on vial
label. | Until expiration date noted on vial
label. |
Conclusions:
Conclusions.
The information provided in the pre-market notification demonstrates that MMUNASSAY PLUS The Information provided in the pro manoe readinate device, for which there is FDA carance. This equivalence was demonstrated through comparison of intended uses and physical properties to a equivalence was demonotiation supplied in the pre-market notification provides commercially available device. The information bupplied in safe and effective for the stated intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top and left side. Inside the circle is a stylized image of an abstract human figure with three curved lines representing the body and head, and two curved lines representing the legs.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 9 2002
Ms. Candice Betz Quality Manager Consolidated Technologies 4401 Freidrich Lane Building 1, Suite 100 Austin, TX 78477-1832
Re: K020237
Trade/Device Name: Immunoassay Plus Control, Levels 1, 2, and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I reserved Product Code: JJY Dated: February 18, 2002 Received: March 13, 2002
Dear Ms. Betz:
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 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
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INDICATIONS FOR USE STATEMENT
510K Number: K020237
Device name:
IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3
Indications for use:
IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and theraputic drugs as listed in this package insert.
↓ Prescription use
Kim An
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number .. 6020237