(44 days)
Not Found
No
The 510(k) summary describes a chemical reagent kit for in vitro diagnostic testing, which does not involve AI or ML technology. The performance studies are standard analytical chemistry evaluations.
No
The device is an in vitro diagnostic reagent used to measure total bilirubin, which aids in diagnosis and treatment monitoring, but it does not directly provide therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "Dri-STAT® Enzymatic Bilirubin Reagent...is intended for use in the in vitro diagnostic determination of total bilirubin...Measurements of total bilirubin...are used in the diagnosis and treatment of liver, hemolytic, hematologic, and metabolic disorders..." This directly indicates its role in diagnosis.
No
The device description explicitly states it is a "reagent kit" containing "two reagent bottles" that are transferred into a "Beckman Coulter User-Defined Cartridge." This describes a physical, chemical component used in an in vitro diagnostic test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device is "intended for use in the in vitro diagnostic determination of total bilirubin in human serum and plasma". It also mentions its use in the "diagnosis and treatment of liver, hemolytic, hematologic, and metabolic disorders". This clearly indicates its purpose is for diagnostic testing performed outside of the body (in vitro) on biological samples.
- Device Description: It describes the device as a "reagent kit" used in conjunction with a calibrator on a "SYNCHRON® Systems". Reagents and calibrators used for analyzing biological samples are typical components of IVD devices.
- Performance Studies: The document details performance studies like "method comparison, linearity, and imprecision experiments" which are standard evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device(s): The listing of predicate devices with K numbers (K843174 and K791141) further confirms its classification as a medical device, specifically an IVD, as K numbers are associated with FDA clearances for medical devices, including IVDs.
N/A
Intended Use / Indications for Use
Dri-STAT® Enzymatic Bilirubin Reagent, in conjunction with the SYNCHRON® Systems Bilirubin Calibrator, is intended for use in the in vitro diagnostic determination of total bilirubin in human serum and plasma as a User Defined Reagent (UDR) application on SYNCHRON® Systems.
Measurements of total bilirubin in serum and plasma are used in the diagnosis and treatment of liver diseases, hemolytic anemia, and biliary obstruction, hepatitis and cirrhosis.
Product codes
JFM
Device Description
The Dri-STAT® Enzymatic Bilirubin Reagent Enzymatic Bilirubin may be used in conjunction with the SYNCHRON® on the family of Oynomen Cystom ragent kit contains two reagent bottles that Systems Billirabili CallBraterferred into a Beckman Coulter User-Define Cartridge
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in moung of Substantial oquivalence is demonstrated through method comparison, linearity, and imprecision experiments.
Method Comparison Study Results:
Candidate Method: Dri-STAT TBE Reagent On Synchron LX System
Sample Type: Serum
Slope: 1.031
Intercept: 0.016
R: 0.9997
n: 70
Predicate Method: Beckman Coulter Dri-STAT Enzymatic Bilirubin on Cobas Fara
Candidate Method: Dri-STAT TBE Reagent On Synchron CX System
Sample Type: Serum
Slope: 1.004
Intercept: 0.004
R: 0.9997
n: 70
Predicate Method: Beckman Coulter Dri-STAT Enzymatic Bilirubin on Cobas Fara
Estimated Imprecision:
Within-Run Imprecision:
Sample: Serum Control 1, Mean: 0.7 mg/dL, S.D.: 0.03 mg/dL, %C.V.: 4.8, N: 80
Sample: Serum Control 2, Mean: 4.0 mg/dL, S.D.: 0.05 mg/dL, %C.V.: 1.1, N: 80
Sample: Serum Control 3, Mean: 7.3 mg/dL, S.D.: 0.08 mg/dL, %C.V.: 1.1, N: 80
Sample: Human Pool, Mean: 19.7 mg/dL, S.D.: 0.12 mg/dL, %C.V.: 0.6, N: 80
Total Imprecision:
Sample: Serum Control 1, Mean: 0.7 mg/dL, S.D.: 0.03 mg/dL, %C.V.: 4.8, N: 80
Sample: Serum Control 2, Mean: 4.0 mg/dL, S.D.: 0.06 mg/dL, %C.V.: 1.4, N: 80
Sample: Serum Control 3, Mean: 7.3 mg/dL, S.D.: 0.11 mg/dL, %C.V.: 1.5, N: 80
Sample: Human Pool, Mean: 19.7 mg/dL, S.D.: 0.47 mg/dL, %C.V.: 2.4, N: 80
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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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).
Not Found
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.
0
DEC 16 2005
Dri-STAT® Enzymatic Bilirubin Reagent and Calibrator Section 510(k) Supplemental Information, K053090
510(k) Summary Dri-STAT® Enzymatic Bilirubin Reagent
1.0 Submitted By:
Eri Hirumi Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-110 Brea, California 92822-8000 Telephone: (714) 961-4389 FAX: (714) 961-4234
2.0 Date Submitted:
November 1, 2005
3.0 Device Name(s):
3.1 Proprietary Names
Dri-STAT® Enzymatic Bilirubin Reagent SYNCHRON® Systems Bilirubin Calibrator
3.2 Classification Name
Bilirubin (total or direct) test system (21 CFR § 862.1110) Calibrator (21 CFR § 862.1150)
4.0 Predicate Device:
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|----------------------------------------------|-----------------------------------------------|----------------------------|------------------|
| Dri-STAT®
Enzymatic Bilirubin
Reagent | Dri-STAT®
Enzymatic Bilirubin
Reagent | Beckman
Coulter, Inc. * | K843174 |
| SYNCHRON®
Systems Bilirubin
Calibrator | SYNCHRON®
Systems Bilirubin
Calibrator | Beckman
Coulter, Inc.* | K791141 |
*Beckman Coulter, Inc., Brea, CA
SSE1
1
Dri-STAT® Enzymatic Bilirubin Reagent and Calibrator Section 510(k) Supplemental Information, K053090
Description: 5.0
The Dri-STAT® Enzymatic Bilirubin Reagent Enzymatic Bilirubin may be used The Dir-OTAT® Enzymation Billians in conjunction with the SYNCHRON® on the family of Oynomen Cystom ragent kit contains two reagent bottles that Systems Billirabili CallBraterferred into a Beckman Coulter User-Define Cartridge
Intended Use: 6.0
Dri-STAT® Enzymatic Bilirubin Reagent, in conjunction with the SYNCHRON® Systems Bilirubin Calibrator, is intended for use in the in vitro diagnostic Systems Billirubin Sullirubin in human serum and plasma as a User Defined Reagent (UDR) application on SYNCHRON® Systems.
Comparison to Predicate(s): 7.0
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Similarities | ||
|---|---|---|
| TBE | ||
| Reagent | Intended Use | Same as Beckman Coulter |
| Methodology | Dri-STAT® Enzymatic Bilirubin | |
| Reagent, | ||
| Enzymatic Bilirubin on Cobas Fara | ||
| Reactive Ingredients | ||
| Sample Types | ||
| Shelf Life | ||
| Reaction Type | ||
| Calibrator | ||
| Differences | ||
| Instrument Platforms | SYNCHRON® Systems | |
| Vs | ||
| Cobas Fara | ||
| Analytical Range | Up through 35 mg/dL on predicate | |
| 0.2-25 mg/dL on candidate | ||
| Reference Intervals | 0.1-1.0 mg/dL on predicate | |
| 0.3-1.2 mg/dL per literature | ||
| Wavelength | 465 nm on predicate | |
| 470 and 520 nm on candidate | ||
| Reaction Volumes | 0.05; 1.00; 0.08 mL on predicate | |
| 10; 200; 16 µL on candidate |
SSE2
2
Summary of Performance Data: 8.0
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in moung of Substantial oquivalence is demonstrated through method comparison, linearity, and imprecision experiments.
| Candidate
Method | Sample
Type | Slope | Inter-
cept | R | n | Predicate Method |
|-----------------------------------------------------|----------------|-------|----------------|--------|----|---------------------------------------------------------------------|
| Dri-STAT
TBE Reagent
On Synchron
LX System | Serum | 1.031 | 0.016 | 0.9997 | 70 | Beckman Coulter
Dri-STAT
Enzymatic Bilirubin
on Cobas Fara |
| Dri-STAT
TBE Reagent
On Synchron
CX System | Serum | 1.004 | 0.004 | 0.9997 | 70 | Beckman Coulter
Dri-STAT
Enzymatic Bilirubin
on Cobas Fara |
Dri-STAT Enzymatic Bilirubin Method Comparison Study Results__________________________________________________________________________________________________________________
Dri-STAT Enzymatic Bilirubin Estimated Imprecision
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N | ||
|---|---|---|---|---|---|---|
| Within-Run Imprecision | ||||||
| Serum Control 1 | 0.7 | 0.03 | 4.8 | 80 | ||
| Serum Control 2 | 4.0 | 0.05 | 1.1 | 80 | ||
| Serum Control 3 | 7.3 | 0.08 | 1.1 | 80 | ||
| Human Pool | 19.7 | 0.12 | 0.6 | 80 | ||
| Total Imprecision | ||||||
| Serum Control 1 | 0.7 | 0.03 | 4.8 | 80 | ||
| Serum Control 2 | 4.0 | 0.06 | 1.4 | 80 | ||
| Serum Control 3 | 7.3 | 0.11 | 1.5 | 80 | ||
| Human Pool | 19.7 | 0.47 | 2.4 | 80 |
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
SSE3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 16 2005
Ms. Eri Hirumi Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. Brea, CA 92822
K053090 Re:
Trade/Device Name: Dri- STAT® Enzymatic Bilirubin Reagent Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: JFM Dated: November 1, 2005 Received: November 2, 2005
Dear Ms. Hirumi:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to 10gm) the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costiletter (110) that to nevice, subject to the general controls provisions of the Act. The r ou may, there's or visions of the Act include requirements for annual registration, listing of general controle profice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device to such additional controls. Existing major regulations affecting your device it may be subject to bach additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 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 that I Dri has intact a and regulations administered by other Federal agencies. You must or any I cutral statutes and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing pactice 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) I mis letter will anow you to ough finding of substantial equivalence of your device to a legally promation in the 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 you coons 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 Four may 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,
Alberto Gutz
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Dri-STAT® Enzymatic Bilirubin Reagent and Calibrator Section 510(k) Supplemental Information, K053090
Indications for Use
510(k) Number (if known): K053090
Device Name: Dri-STAT® Enzymatic Bilirubin Reagent
Indications For Use:
Dri-STAT® Enzymatic Bilirubin Reagent, in conjunction with the SYNCHRON® Dri-STAT Enzymatic Billrabili Reagend, in the in vitro diagnostic Systemination of total bilirubin in human serum and plasma as a User Defined determination on SYNCHRON® Systems.
Measurements of total bilirubin in serum and plasma are used in the diagnosis Measurements of total Bhilary obstruction, hepatitis and cirrhosis
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Page 1 of
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Catharina
Office of In Vitro Diagnostic Device
Evaluation and Safety
(k) K053090
File: TBE RSP1_final.doc
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