(21 days)
Not Found
No
The document describes a quality control serum for a laboratory assay and explicitly states that AI, DNN, or ML were not found.
No
The device is a control set serum used for quality control of an assay, not for treating a disease or condition.
No
This device is a control serum used for quality control and monitoring the accuracy and precision of an assay, not for directly diagnosing a patient's condition.
No
The device is a control serum, which is a physical substance used for quality control of an assay, not a software program.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quality control of the Boehringer Mannheim Tinaquant ß2-microglobulin assay" and "monitoring accuracy and precision" of this assay. This indicates it's used in vitro (outside the body) to assess the performance of another diagnostic test.
- Device Description: The description details the composition of the control material (human serum albumin, ß2-microglobulin, stabilizers) and how it's manufactured and value assigned. This is consistent with the description of a reagent or control used in laboratory testing.
- Predicate Device: The mention of a predicate device, the "Abbott Imx β2-microglobulin assay (K890421)," further supports its classification as an IVD. Predicate devices are typically other legally marketed IVDs that a new device is compared to for regulatory clearance.
While the document doesn't contain all the information typically found in a full IVD submission (like performance data, user information, etc.), the core elements of its intended use and description clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Boehringer Mannheim beta2-microglobulin Control Set Serum is used for the quality control of the Boehringer Mannheim Tinaquant beta2-microglobulin assay.
The beta2-microglobulin Control Set Serum is used for monitoring accuracy and precision of the Boehringer Mannheim Tinaquant beta2-microglobulin assay.
Product codes
JJX
Device Description
The Boehringer Mannheim beta2-microglobulin Control Set Serum is manufactured using human serum albumin, beta2-microglobulin, and stabilizers. The analyte is appropriately spiked into the control matrix to the correct control concentration levels. The controls are in process checked, and a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator.
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)
Performance Characteristics:
- Dose assignment and stability
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
AUG ୧ ବିଷ୍ଣୟ
510(k) Summary
ﺍﻟﻘﻴﺎﺩﺓ
(
ﺍﻟﻤﻮﺿﻮﻉ: ﺍ
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.
Submitter
name,
address,
contact | Boehringer Mannheim Corporation
4300 Hacienda Drive
Pleasanton, CA 94588-2722
(925) 730-8413
Fax number: (925) 225-0654 |
| | Contact Person: Julie A. Smith |
| | Date Prepared: July 13, 1998 |
| 2.
Device Name | Proprietary name: β2-microglobulin Control Set Serum |
| | Common name: Controls |
| | Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3.
Predicate
device | The Boehringer Mannheim β2-microglobulin Control Set Serum is a new
product. |
| | The Boehringer Mannheim β2-microglobulin Control Set Serum is
substantially equivalent to other products in commercial distribution intended
for similar use. Most notably it is substantially equivalent to the β2-
microglobulin controls contained in the Abbott Imx β2-microglobulin assay
(K890421). |
| 4.
Device
Description | The Boehringer Mannheim β2-microglobulin Control Set Serum is
manufactured using human serum albumin, β2-microglobulin, and stabilizers.
The analyte is appropriately spiked into the control matrix to the correct
control concentration levels. The controls are in process checked, and a value
assignment process is done via a comparison to an analyte specific (and
chemistry specific) calibrator. |
| 5.
Intended use | Boehringer Mannheim β2-microglobulin Control Set Serum is used for the
quality control of the Boehringer Mannheim Tinaquant β2-microglobulin
assay. |
| 6.
Comparison
to predicate
device | The Boehringer Mannheim β2-microglobulin Control Set Serum is substantially
equivalent to other products in commercial distribution intended for similar use.
Most notably it is substantially equivalent to the β2-microglobulin controls
contained in the Abbott Imx β2-microglobulin assay (K890421).
The following table compares the Boehringer Mannheim β2-microglobulin
Controls Set Serum with Abbott β2-microglobulin controls. Specific data on
the performance of the controls have been incorporated into the draft labeling in
attachment 5. Labeling for the predicate device is provided in attachment 6. |
| | Similarities:
• Similar intended use
• Same analyte |
Continued on next page
1
510(k) Summary, Continued
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2
510(k) Summary, Continued
Differences:
| Feature | β2-microglobulin Control Set
Serum | Abbott β2-microglobulin control |
|----------------|---------------------------------------------------------------------------|---------------------------------|
| Control levels | 2.50 mg/L | 0.2 mg/L |
| | 5.50 mg/L | 0.6 mg/L |
| | | 2 mg/L |
| Matrix | Human Serum | Buffer with protein stabilizers |
| Preparation | Lyophilized calibrators requiring
reconstitution with distilled water. | Ready to use liquid calibrators |
6.
.
. ......
14 page
| Comparison
| to predicate | Performance Characteristics: | |
|---|---|---|
| device, (cont.) | . | |
| Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children C |
- Dose assignment and stability
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 6 1638
Julie A. Smith Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900
Re : K982471 ß2-microglobulin Control Set Requlatory Class: I Product Code: JJX Dated: July 13, 1998 Received: July 16, 1998
Dear Ms. Smith:
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 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, Druq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ਼ੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements; as setforth in the Quality System Requlation (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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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 requlations.
4
Page 2
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/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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
5
K982471 510(k) Number (if known): NA
Device Name: ß2-microglobulin Control Set Serum
Indications For Use:
The ß2-microglobulin Control Set Serum is used for monitoring accuracy and precision of the Boehringer Mannheim Tinaquant ß2-microglobulin assay.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| Prescription Use | |||
| (Per 21 CFR 801.109) | |||
| OR | |||
| Over-The-Counter Use | |||
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K982471
Boehringer Mannheim page 23 B2-Microglobulin Control Set Serum