(26 days)
The Dimension® RxL Max™ with StreamLAB® Analytical Workeell and Sample Transfer Module is a discrete photometric chemistry analyzer for clinical use intended to duplicate analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
The modified device includes the connection of a StreamLAB® Analytical Workcell and Sample Transfer Module. These are used to prepare specimens from the human body for testing on the Dimension® RxL Max™ system.
This submission (K043546) is a Special 510(k) for a device modification; therefore, the provided document does not contain an acceptance criteria table or a detailed study report with performance metrics. The submission focuses on demonstrating substantial equivalence to a predicate device after a modification, rather than proving performance against specific acceptance criteria for a novel device.
The modification involves connecting a StreamLAB® Analytical Workcell and Sample Transfer Module to the existing Dimension® RxL Max™ Clinical Chemistry System. The core functionality and assay performance are stated to be "the same" as the predicate device.
However, based on the provided text, here's what can be extracted or inferred about the device and the nature of this submission:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given text. As a Special 510(k) for a device modification, the manufacturer primarily asserts that the modified device has "the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device." Therefore, explicit acceptance criteria and corresponding reported device performance for the modified components are not detailed, as the focus is on maintaining equivalence to the existing, cleared predicate.
2. Sample sized used for the test set and the data provenance
This information is not provided in the given text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the given text.
4. Adjudication method for the test set
This information is not provided in the given text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study is not applicable to this device. This is a clinical chemistry analyzer, not a device requiring human reader interpretation of images or other subjective data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone clinical chemistry analyzer. The device itself performs the analysis; human interpretation is involved in reviewing the results it produces. However, the document does not describe "standalone performance" in the context of comparing an algorithm to human performance, as it's an automated analytical system.
7. The type of ground truth used
This information is not explicitly stated. For clinical chemistry analyzers, ground truth would typically be established through reference methods (e.g., gold standard laboratory tests) for accuracy and precision studies, but such studies are not described for this specific modification. The submission implies that the "assay performance characteristics" are the same as the predicate, which would have had its performance validated against appropriate ground truth.
8. The sample size for the training set
This information is not provided in the given text. Given that this is a modification to an existing device, it's unlikely that a new "training set" for an algorithm, as understood in AI/ML, would be applicable or explicitly mentioned in such a submission.
9. How the ground truth for the training set was established
This information is not provided in the given text.
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JAN | 8 2005
Special 510(k): Device Modification
Dimension® RxL Max™ Clinical Chemistry System with StreamLAB® Analytical Workcell and Samle Transfer Module
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Dimension® RxL Max™ Clinical Chemistry System with Automation System
1. Manufacturer and Contact Information:
| Manufacturer: | Dade Behring Inc.101 Silvermine Road.Brookfield, CT 06904 |
|---|---|
| Contact Information: | Stanley P. Gorak.Quality Systems and Compliance ManagerDade Behring, Inc.500 GBC Drive, M/S 514P.O. Box 6101Newark, DE 19714-6101Tel: 302-631-7458Fax: 408 -631-6299 |
Date Summary Prepared: 2.
December 16, 2004
3. Device Trade Namel Common Name:
Dimension® RxL Max™ / StreamLAB® Analytical Workcell/ Sample Transfer Module
Device Classification Name: 4.
Analyzer, chemistry (photometric, discrete), for clinical use has been classified as Class I, JJE by the Clinical Chemistry and Clinical Toxicology Devices Panel, (21 CFR 862.2160). No performance standards have been established under Section 514 of the Food, Drug, and Cosmetic Act.
ક. Intended Use:
The Dimension RXL Max™ clinical chemistry system with automation system is a discrete, randomaccess, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids. It can also process high-sensitivity chromiumbased heterogeneous immunoassays with its HM module.
Device Description: 6.
The modified device includes the connection of a StreamLAB® Analytical Workcell and Sample Transfer Module. These are used to prepare specimens from the human body for testing on the Dimension® RxL Max™ system.
7. Substantial Equivalence
The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device. In conclusion the modified Dimension® RxL Max ™ with automation system is substantially equivalent to the predicate Dimension RxL Max™ .
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Stanley P. Gorak, Jr. Quality Systems and Compliance Manager Dade Behring Inc. 500 GBC Drive, M/S 514 P.O. Box 6101 Newark, DE 19714-6101
Re: K043546 Trade/Device Name: Dimension® RxL Max™ with StreamLAB® Analytical Workcell and Sample Transfer Module Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDQ, CDT, CEC, CEK, CEM, CHO, CFI, CFQ, CFR, CGS, CGX, CGZ, CHH, CHI, CIC, CIG, CIT, CJF. CIW, CKA, CKE, C/W, DBI. DCF, DCN, DDG, DDR, DHA, DIH, DIO, DIP, DIS, DIG, DIR. DKI, DKZ, DI.Z, DMI, JFJ, JFL, JGJ, JHC, JHM, JHT, JIHY, JIF, JIH, JJE, JLW, JMG, JMO, JQB, JXM, KHP, KHQ, KHS, KLB, KLI, KLR, KLS, KLT, KXT, LAN, LAR, LCD, LCM, LCP, LDJ, LDP, LEG, LEH, LFM, MKW, MMI, MRR, NBC Dated: December 21, 2004 Received: December 23, 2004
JAN 1 8 2005
Dear Mr. Gorak:
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 (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Txisting major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 many 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/industry/support/index.html
Sincerely yours,
Cornelia B. Rooks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (If Known):
Device(s) Name(s):
Dimension@ RxL Max™ with StreamLAB® Analytical Workeell and Sample Transfer Module
Indications for Use:
The Dimension® RxL Max™ with StreamLAB® Analytical Workeell and Sample Transfer Module is a discrete photometric chemistry analyzer for clinical use intended to duplicate analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
Prescription Use
(Part 21 CFR 801 Subpart D)
✓
and/or
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
5104: K043546
Dade Behring, Inc.
§ 862.1705 Triglyceride test system.
(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.