(120 days)
Not Found
No
The summary describes a reagent kit for in vitro diagnostic testing and does not mention any AI or ML components or functionalities. The performance studies focus on standard analytical chemistry metrics.
No.
This device is an in vitro diagnostic reagent used to determine levels of acid phosphatase in human serum, which is for diagnostic purposes, not therapeutic intervention.
Yes
The device is described as an "in vitro diagnostic" for determining acid phosphatase in human serum.
No
The device description clearly states it is a reagent kit containing physical components (reagent bottles, buffer) that are manually transferred and used on a hardware system (SYNCHRON® Systems). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagent is "intended for use in the in vitro diagnostic determination of total acid phosphatase and non-prostatic acid phosphatase in human serum". The phrase "in vitro diagnostic determination" is a clear indicator of an IVD.
- Device Description: The description mentions that the reagent is used on "SYNCHRON® Systems", which are laboratory instruments used for performing diagnostic tests on biological samples.
- Performance Studies: The document describes performance studies (method comparison and imprecision) conducted to demonstrate the safety and effectiveness of the device for its intended diagnostic use.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K821674) indicates that this device is being compared to a previously cleared IVD device.
All these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Dri-STAT® Reagent ACP is intended for use in the in vitro diagnostic determination of total acid phosphatase and non-prostatic acid phosphatase in human serum as a User Defined Reagent (UDR) application on SYNCHRON® Systems.
Product codes (comma separated list FDA assigned to the subject device)
CKB
Device Description
The Dri-STAT® Reagent ACP may be used on the family of Synchron Systems. The reagent kit contains 20 reagent bottles that needs to be manually transferred into a Beckman Coulter User-Define Cartridge. Also with 1 bottle of Acetate Buffer. The reagent kit contains a bottle of Acetate Buffer along with a sample treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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 commercial distribution. Equivalence is demonstrated through method comparison, linearity, and imprecision experiments.
Dri-STAT Reagent ACP Method Comparison Study Results:
Candidate Method: Dri-STAT Reagent ACP On Synchron LX Systems, Sample Type: Serum TACP, Slope: 1.093, Intercept: 0.143, R: 0.994, n: 94, Predicate Method: Dri-STAT Reagent ACP On Cobas Fara
Candidate Method: Dri-STAT Reagent ACP On Synchron LX Systems, Sample Type: Serum NPAP, Slope: 1.066, Intercept: -0.197, R: 0.979, n: 47, Predicate Method: Dri-STAT Reagent ACP On Cobas Fara
Candidate Method: Dri-STAT Reagent ACP On Synchron CX Systems, Sample Type: Serum TACP, Slope: 1.075, Intercept: 0.460, R: 0.997, n: 94, Predicate Method: Dri-STAT Reagent ACP On Cobas Fara
Candidate Method: Dri-STAT Reagent ACP On Synchron CX Systems, Sample Type: Serum NPAP, Slope: 1.088, Intercept: -0.172, R: 0.994, n: 47, Predicate Method: Dri-STAT Reagent ACP On Cobas Fara
Dri-STAT Reagent ACP Estimated Imprecision - TACP:
Within-Run Imprecision:
Sample: Serum Control 1, Mean (U/L): 3.81, S.D. (U/L): 0.18, %C.V.: 4.72, N: 80
Sample: Serum Control 2, Mean (U/L): 20.6, S.D. (U/L): 0.26, %C.V.: 1.28, N: 80
Sample: Serum Control 3, Mean (U/L): 37.0, S.D. (U/L): 0.50, %C.V.: 1.35, N: 80
Sample: Human Pool, Mean (U/L): 35.5, S.D. (U/L): 0.58, %C.V.: 1.63, N: 80
Total Imprecision:
Sample: Serum Control 1, Mean (U/L): 3.81, S.D. (U/L): 0.19, %C.V.: 4.99, N: 80
Sample: Serum Control 2, Mean (U/L): 20.6, S.D. (U/L): 0.35, %C.V.: 1.70, N: 80
Sample: Serum Control 3, Mean (U/L): 37.0, S.D. (U/L): 0.64, %C.V.: 1.73, N: 80
Sample: Human Pool, Mean (U/L): 35.5, S.D. (U/L): 0.91, %C.V.: 2.56, N: 80
Dri-STAT Reagent ACP Estimated Imprecision - NPAP:
Within-Run Imprecision:
Sample: Serum Control 1, Mean (U/L): 2.60, S.D. (U/L): 0.21, %C.V.: 8.08, N: 80
Sample: Human Pool, Mean (U/L): 2.96, S.D. (U/L): 0.24, %C.V.: 8.11, N: 80
Total Imprecision:
Sample: Serum Control 1, Mean (U/L): 2.60, S.D. (U/L): 0.21, %C.V.: 8.08, N: 80
Sample: Human Pool, Mean (U/L): 2.96, S.D. (U/L): 0.29, %C.V.: 9.80, N: 80
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 862.1020 Acid phosphatase (total or prostatic) test system.
(a)
Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.(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.
0
510(k) Summary Dri-STAT® ACP Reagent
1.0 Submitted By:
APR 26 2006
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:
December 23, 2005
3.0 Device Name(s):
3.1 Proprietary Names Dri-STAT® ACP Reagent
Classification Name 3.2 Acid phosphatase (total or prostatic) test system (21 CFR § 862.1020)
4.0 Predicate Device:
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|-------------------------------------------------|-------------------------------------------|---------------------------|------------------|
| Dri-STAT® Reagent
ACP on Synchron
Systems | Dri-STAT® Reagent
ACP On Cobas
Fara | Beckman
Coulter, Inc.* | K821674 |
*Beckman Coulter, Inc., Brea, CA
1
5.0 Description:
The Dri-STAT® Reagent ACP may be used on the family of Synchron Systems. The reagent kit contains 20 reagent bottles that needs to be manually transferred into a Beckman Coulter User-Define Cartridge. Also with 1 bottle of Acetate Buffer. The reagent kit contains a bottle of Acetate Buffer along with a sample treatment.
6.0 Intended Use:
Dri-STAT® Reagent ACP is intended for use in the in vitro diagnostic determination of total acid phosphatase and non-prostatic acid phosphatase in human serum as a User Defined Reagent (UDR) application on SYNCHRON® Systems.
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Similarities | |
|---|---|
| Intended Use | Same as Beckman Coulter |
| Methodology | Dri-STAT® ACP Reagent, |
| Reactive Ingredients | on Cobas Fara |
| Sample Types | |
| Shelf Life | |
| Reaction Type | |
| Differences | |
| Instrument Platforms | Cobas Fara (Predicate) vs. |
| Synchron® Systems (candidate) | |
| Reference Intervals @ 37°C | |
| Total Acid Phosphatase | |
| (TACP) | ≤5.4 U/L male on predicate |
| 2.5-11.7 U/L male per literature | |
| Reference Intervals @ 37°C | |
| Non-prostatic Acid | |
| Phosphatase (NPAP) | ≤1.2 U/L male on predicate |
| 0.2-3.5 U/L male per literature | |
| Wavelength | 405 nm on predicate |
| 410 nm on candidate | |
| Analytical Range | Predicate: 0 - 38 U/L |
| Candidate: 2 - 38 U/L | |
| Reaction Volumes | 0.20; 3.00; 0.025 mL on predicate |
| 25; 200; 6 µL on candidate |
2
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, linearity, and imprecision experiments.
| Candidate Method | Sample
Type | Slope | Inter-
cept | R | n | Predicate Method |
|------------------------------------------------------|----------------|-------|----------------|-------|----|------------------------------------------|
| Dri-STAT
Reagent ACP
On Synchron LX
Systems | Serum
TACP | 1.093 | 0.143 | 0.994 | 94 | Dri-STAT
Reagent ACP
On Cobas Fara |
| Dri-STAT
Reagent ACP
On Synchron LX
Systems | Serum
NPAP | 1.066 | -0.197 | 0.979 | 47 | Dri-STAT
Reagent ACP
On Cobas Fara |
| Dri-STAT
Reagent ACP
On Synchron CX
Systems | Serum
TACP | 1.075 | 0.460 | 0.997 | 94 | Dri-STAT
Reagent ACP
On Cobas Fara |
| Dri-STAT
Reagent ACP
On Synchron CX
Systems | Serum
NPAP | 1.088 | -0.172 | 0.994 | 47 | Dri-STAT
Reagent ACP
On Cobas Fara |
Dri-STAT Reagent ACP Method Comparison Study Results
Dri-STAT Reagent ACP Estimated Imprecision - TACP
| Sample | Mean (U/L) | S.D. (U/L) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Serum Control 1 | 3.81 | 0.18 | 4.72 | 80 |
| Serum Control 2 | 20.6 | 0.26 | 1.28 | 80 |
| Serum Control 3 | 37.0 | 0.50 | 1.35 | 80 |
| Human Pool | 35.5 | 0.58 | 1.63 | 80 |
| Total Imprecision | ||||
| Serum Control 1 | 3.81 | 0.19 | 4.99 | 80 |
| Serum Control 2 | 20.6 | 0.35 | 1.70 | 80 |
| Serum Control 3 | 37.0 | 0.64 | 1.73 | 80 |
| Human Pool | 35.5 | 0.91 | 2.56 | 80 |
3
| Sample | Mean (U/L) | S.D. (U/L) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Serum Control 1 | 2.60 | 0.21 | 8.08 | 80 |
| Human Pool | 2.96 | 0.24 | 8.11 | 80 |
| Total Imprecision | ||||
| Serum Control 1 | 2.60 | 0.21 | 8.08 | 80 |
| Human Pool | 2.96 | 0.29 | 9.80 | 80 |
Dri-STAT Reagent ACP Estimated Imprecision - NPAP
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.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Eri Hirumi Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. M/S W-110 Brea, CA 92822-8000
APR 2 6 2006
Re: K053612
Trade/Device Name: Dri-STAT® Reagent ACP Regulation Number: 21 CFR§862.1020 Regulation Name: Acid Phosphatase (total or prostatic) test system Regulatory Class: Class II Product Code: CKB Dated: March 22, 2006 Received: March 23, 2006
Dear Mr. Hirumi:
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 (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing 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 or any 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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Page 2 -
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.
Albert Gutt
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
6
Indications for Use
510(k) Number (if known): K053612
Dri-STAT® REAGENT ACP Device Name:
Indications For Use:
Reagent ACP is intended for use in the in vitro diagnostic Dri-STAT® determination of total acid phosphatase and non-prostatic acid phosphatase in human serum as a User Defined Reagent (UDR) application on SYNCHRON® Systems.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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)
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Office Evalu
Diagnostic Devic "fate,