(87 days)
K-945651
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No
The document describes a quality control material for immunological tests and does not mention any AI or ML components.
No
This device is a quality control material intended to monitor the performance of clinical immunological test procedures, not to treat or diagnose a disease.
No
This device is described as a "quality control material intended to monitor the performance of clinical immunological test procedures". It is used to check the accuracy of other tests, not to diagnose a patient's condition.
No
The device is a lyophilized human serum based assayed quality control material, which 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 "intended to monitor the performance of clinical immunological test procedures that analyze immunoglobulins and other serum proteins." This clearly indicates it's 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" and is used to "monitor the performance of test procedures that analyze immunoglobulin and other proteins in serum." This further supports its use in laboratory settings for diagnostic purposes.
- Anatomical Site: The mention of "serum" confirms it's used with a biological sample obtained from the body, which is characteristic of IVDs.
- Intended User / Care Setting: "Clinical immunological test procedures" points to its use in a clinical laboratory setting for diagnostic testing.
- Predicate Device: The presence of a predicate device (K-945651 LIQUICHEK IMMUNOLOGY CONTROL) which is also an immunology control, strongly suggests this device falls under the same regulatory category, which is IVD.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Qualitrol Immunology Control is a Iyophilized human serum based assayed quality control material intended to monitor the performance of serum immunological test procedures that analyze immunoglobulins and other serum proteins.
Qualitrol Immunology Control, Level 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunological test procedures that analyze immunoglobulins and other serum proteins.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Qualitrol Immunology Control, is designed to monitor the performance of test procedures that analyze immunoqlobulin and other proteins in serum. Human origin components are added to a human serum based matrix. The product contains 0.1% sodium azide. Qualitrol Immunology Control will be offered in three levels of 5.0 mL fill vials.
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)
The information provided in the pre-market notification demonstrates that Qualitrol Immunology Control is substantially equivalent to the predicate device, for which there is FDA clearance. This equivalence was demonstrated through comparison of intended uses and physical properties to a commercially available device. The information supplied in the pre-market notification provides reasonable assurance that Qualitrol Immunology Control is safe and effective for the stated intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K-945651
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.
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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).
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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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NOV 1 2 1999
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: _ _ 992720
SeraCare Technology, Inc. DBA Consolidated Technologies Submitter: 2170 Woodward Street Austin, TX 78744-1832 Phone: (512) 445-5100 Fax: (512) 445-5515
Preparation date: August 13, 1999 Contact: Rusty Sewell
Product name (trade & common):
Proprietary: Qualitrol Immunology Control, Levels 1, 2 and 3 Common: Not Applicable
Classification name:
Class 1 . Product code: JJY 21 CFR 862:1660 : Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
Predicate device:
LIQUICHEK IMMUNOLOGY CONTROL, BIO-RAD Laboratories K-945651
Device description:
Qualitrol Immunology Control, is designed to monitor the performance of test procedures that analyze immunoqlobulin and other proteins in serum. Human origin components are added to a human serum based matrix. The product contains 0.1% sodium azide. Qualitrol Immunology Control will be offered in three levels of 5.0 mL fill vials.
Intended use:
Qualitrol Immunology Control is a Iyophilized human serum based assayed quality control material intended to monitor the performance of serum immunological test procedures that analyze immunoglobulins and other serum proteins.
Labeling: Vial labels see Attachments I Secondary Container label, see Attachments II Package Insert, see Attachment III
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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 Qualitrol Immunology Control and the predicate device.
| Device
Characteristic | Qualitrol Immunology
Control | Liquichek™ Immunology Plus
Control |
|--------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended use | Assayed quality control serum for
monitoring performance of serum
immunological test procedures. | Assayed quality control serum for
monitoring precision of laboratory
testing procedures. |
| Matrix | Human Serum | Human Serum |
| Form | Lyophilized | Liquid |
| Analytes | 26 analytes of clinical significance
that may be found in serum. | 24 analytes |
| Storage | 2-8°C | 2-8°C |
| Stability | Until expiration date noted on vial
label. | Until expiration date noted on vial
label |
Conclusions:
The information provided in the pre-market notification demonstrates that Qualitrol Immunology Control is substantially equivalent to the predicate device, for which there is FDA clearance. This equivalence was demonstrated through comparison of intended uses and physical properties to a commercially available device. The information supplied in the pre-market notification provides reasonable assurance that Qualitrol Immunology Control is safe and effective for the stated intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines representing hair or fabric.
NOV 1 2 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Rusty Sewell Product Development Engineer SeraCare Technology, Inc. DBA, Consolidated Technologies 2170 Woodward Street Austin, Texas 78744-1832
K992770 Re:
Trade Name: Qualitrol Immunology Control, Level 1, 2 and 3 Regulatory Class: I Product Code: JJY Dated: August 13, 1999 Received: August 17, 1999
Dear Mr. Sewell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response 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 Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrl/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
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510(k) Number (if known): $993720
Device Name:__________________________________________________________________________________________________________________________________________________________________
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Indications For Use:
Qualitrol Immunology Control, Level 1, 2 and 3 Device name: Indications for use:
Qualitrol Immunology Control, Level 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunological test procedures that analyze immunoglobulins and other serum proteins.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K992770 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |