(26 days)
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No
The summary describes a standard clinical chemistry analyzer and its associated sample preparation modules. There is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is a chemistry analyzer designed to measure analytes in human specimens, not to treat or cure a disease.
Yes
The device is described as 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 function of measuring analytes for clinical use makes it a diagnostic device.
No
The device description explicitly mentions hardware components like the StreamLAB® Analytical Workcell and Sample Transfer Module, which are used to prepare specimens. This indicates it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "discrete photometric chemistry analyzer for clinical use intended to duplicate analytical procedures by performing automatically various steps... This device is intended for use in conjunction with certain materials to measure a variety of analytes." This describes a device used to perform tests on samples taken from the human body to provide information for diagnosis or monitoring.
- Device Description: The description mentions it's used to "prepare specimens from the human body for testing." This further confirms its role in the diagnostic process.
- Clinical Use: The intended user/care setting is "clinical use," which is a common setting for IVD devices.
The core function of the device is to analyze samples from the human body to measure analytes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
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
Device Description
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.
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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§ 862.1705 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.
0
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 Manager
Dade Behring, Inc.
500 GBC Drive, M/S 514
P.O. Box 6101
Newark, DE 19714-6101
Tel: 302-631-7458
Fax: 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™ .
1
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
3
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.