(4 days)
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No
The document describes a quality control material for immunoassay systems and does not mention any AI or ML components.
No
This device is a quality control product for immunoassays, not a direct treatment or diagnostic tool for patients. It is used to ensure the accuracy and precision of laboratory tests.
No
Explanation: The device is described as a quality control material for immunoassays, used to monitor the accuracy and precision of other diagnostic tests. It does not directly diagnose a condition in a patient.
No
The device description clearly states it is a "bilevel lyophilized preparation of pooled human sera," which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "quality control of the Elecsys CK-MB, Troponin T (CARDIAC T®) and Myoglobin immunoassays using the Elecsys immunoassay systems." This indicates it's used in vitro (outside the body) to assess the performance of other diagnostic tests.
- Device Description: The description confirms it's a "bilevel lyophilized preparation of pooled human sera containing CK-MB (human), Troponin T (human recombinant) and Myoglobin (human) for monitoring the accuracy and precision of Elecsys CK-MB, Troponin T and Myoglobin immunoassays." This further reinforces its role in the in vitro diagnostic process.
- Predicate Device: The mention of a predicate device with the same name and a K number (K962575) strongly suggests it has gone through the regulatory process for IVDs.
While it doesn't directly diagnose a patient's condition, it is an essential component in ensuring the reliability and accuracy of diagnostic tests that do diagnose conditions. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
Boehringer Mannheim Elecsys ® PreciControl Cardiac is intended for use for quality control of the Elecsys CK-MB, Troponin T (CARDIAC T®), and Myoglobin immunoassays using the Elecsys immunoassay systems.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Boehringer Mannheim Elecsys ® PreciControl Cardiac is a bilevel lyophilized preparation of pooled human sera containing CK-MB (human), Troponin T (human recombinant) and Myoglobin (human) for monitoring the accuracy and precision of Elecsys CK-MB, Troponin T and Myoglobin immunoassays.
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.
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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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) 576-3723 |
Contact person: Priscilla A. Hamill
Date prepared: October 1, 1998 |
| 2) Device name | Proprietary name: Boehringer Mannheim Elecsys ® PreciControl Cardiac
Common name: Elecsys ® PreciControl Cardiac
Classification name: Enzyme Controls (assayed and unassayed) |
| 3) Predicate device | We claim substantial equivalence to Elecsys ® PreciControl Cardiac (K962575). |
| 4) Device description | Boehringer Mannheim Elecsys ® PreciControl Cardiac is a bilevel lyophilized preparation of pooled human sera containing CK-MB (human), Troponin T (human recombinant) and Myoglobin (human) for monitoring the accuracy and precision of Elecsys CK-MB, Troponin T and Myoglobin immunoassays. |
क
Continued on next page
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510(k) Summary, Continued
Boehringer Mannheim Elecsys ® PreciControl Cardiac is intended for use for 5) Intended use quality control of the Elecsys CK-MB, Troponin T (CARDIAC T®), and Myoglobin immunoassays using the Elecsys immunoassay systems. Boehringer Mannheim Elecsys ® PreciControl Cardiac is substantially 6) Comparison to the predicate equivalent to other products in commercial distribution intended for similar device use. Most notably, it is substantially equivalent to the current Elecsys ® PreciControl Cardiac controls marketed by Boehringer Mannheim Corporation. These controls were cleared by the FDA based on 510(k) submissions by Boehringer Mannheim. The 510(k) number for the Elecsys ® PreciControl Cardiac is K962575. The intended use of this BM control and the predicate device is the same in that they are intended to be used for the quality control of Elecsys immunoassays for cardiac proteins.
The only significant differences are
- the inclusion of an additional constituent analyte (myoglobin), and .
- the replacement of bovine heart troponin T by human recombinant . troponin T.
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Rockville MD 20850
Food and Drug Administration 2098 Gaither Road
OCT 9 1998
Priscilla A. Hamill · Regulatory Affairs Consultant Boehringer Mannheim Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re: K983492 Elecsys® PreciControl Cardiac Requlatory Class: I Product Code: JJY Dated: October 1, 1998 Received: October 5, 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 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. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 miqht 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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| 510(k) Number (if known): | K983492 |
|---|---|
| --------------------------- | --------- |
Device Name: Boehringer Mannheim Elecsys ® PreciControl Cardiac
Indications for Use: Elecsys ® PreciControl Cardiac is used for quality control of the Elecsys CK-MB, Troponin T (CARDIAC T®) and Myoglobin immunoassays using the Elecsys immunoassay systems.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED)
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 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. K 98 3492
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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/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