(55 days)
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No
The summary describes a calibrator for laboratory assays, which is a chemical reagent used for calibration, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
Explanation: This device is a multi-level calibrator used for the calibration of immunoturbidimetric assays, not for the treatment or diagnosis of a condition in patients.
No
The device is described as a multi-level calibrator used for the calibration of immunoturbidimetric assays, not for directly diagnosing medical conditions. It helps ensure the accuracy of diagnostic tests by providing known concentrations for comparison.
No
The device description explicitly states that the device "consists of multi-level calibrators based on human serum," indicating a physical, biological component, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For calibration of immunoturbidimetric assays on BM/Hitachi systems." This clearly indicates the device is used in vitro (outside the body) to calibrate tests that measure substances in biological samples (serum).
- Device Description: The description states it "consists of multi-level calibrators based on human serum." Calibrators are essential components in many in vitro diagnostic tests to ensure accurate measurement of analytes in patient samples.
- Calibration of Assays: The device is specifically designed to calibrate immunoturbidimetric assays, which are a type of in vitro diagnostic test used to measure the concentration of specific proteins in biological fluids.
The information provided strongly aligns with the definition and function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Preciset® Serum Proteins calibrator is intended to be used in the calibration of immunoturbidimetric assays on the BM/Hitachi systems.
Product codes (comma separated list FDA assigned to the subject device)
75 JIX
Device Description
The Preciset® Serum Proteins consists of multi-level calibrators based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the following immunoturbidimetric assays: Tina-quant® IgA, Tina-quant® IgG, Tina-quant® IgM, Tina-quant ® C3, and Tina-quant ® C4.
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)
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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.
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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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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is 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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K 983469
NOV 25 1998
510(k) Summary
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 |
9115 Hague Rd | |
Indianapolis. IN 46250 | |
(317) 845-2386 |
Contact person: Priscilla A. Hamill
Date prepared: September 28, 1998 |
| 2) Device name | Proprietary name: Preciset® Serum Proteins
Common name: Preciset® Serum Proteins
Classification name: Calibrator, Multi-analyte mixture |
| 3) Predicate device | We claim substantial equivalence to C.f.a.s. Protein Calibrator. The intended use of the above calibrators is the establishment of calibration curves for test systems for the quantitative determination of proteins in serum and plasma. |
| 4) Device description | The Preciset® Serum Proteins consists of multi-level calibrators based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the following immunoturbidimetric assays: Tina-quant® IgA, Tina-quant® IgG, Tina-quant® IgM, Tina-quant ® C3, and Tina-quant ® C4. |
| 5) Intended use | The Preciset® Serum Proteins calibrator is intended to be used in the calibration of immunoturbidimetric assays on the BM/Hitachi systems. |
| 6) Comparison
to the predicate
device | The Preciset ® Serum Proteins calibrator is substantially equivalent to other
products in commercial distribution intended for similar use. Most notably, it
is substantially equivalent to the currently marketed Boehringer Mannheim
C.f.a.s. Protein calibrator. |
| | The intended use of this BM calibrator and the predicate devices is the same
in that they are intended to be used for the calibration of test systems for the
measurement of their labeled analytes. |
| Representative
constituent
levels and
reference
materials | Representative constituent levels and the corresponding reference
material/method are given in the table below. |
| | Representative Constituent Levels, Reference Materials, and
Units |
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510(k) Summary, Continued
Constituent | Level 1 | Level 2 | Level 3 | Level 4 | Level 5 | Reference Material | Units |
---|---|---|---|---|---|---|---|
IgG | 215 | 454 | 982 | 1859 | 3755 | RPPHS | mg/mL |
IgA | 56 | 108 | 236 | 470 | 941 | RPPHS | mg/mL |
IgM | 46 | 88 | 181 | 361 | 724 | RPPHS | mg/mL |
C3 | 40 | 74 | 159 | 330 | NA | RPPHS | mg/mL |
C4 | 6.5 | 12.8 | 27.5 | 56.0 | 110.6 | RPPHS | mg/mL |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, formed by three human profiles facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 25 1998
Ms. Pricilla A. Hamill Requlatory Affairs Consultant BOEHRINGER MANNHEIM CORPORATION 9115 Haque Road P.O. Box 50457 Indianapolis, IN 46250
Re: K983469 Trade Name: Preciset® Serum Proteins Requlatory Class: II Product Code: 75 JIX September 28, 1998 Dated: Received: October 01, 1998
Dear Ms. Hamill:
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 Requlations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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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Page 2
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 requlation (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, "Misbrandinq 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/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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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K983469 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: Preciset ® Serum Proteins
Indications for Use: For calibration of immunoturbidimetric assays on BM/Hitachi systems
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Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional format 1-2-96)
Shan F. Logsdon
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983469