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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Dri-STAT® ACP Reagent, based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in the typical sense of threshold values (e.g., "r-value > 0.95"). Instead, it presents performance data for method comparison and imprecision. The implicit acceptance criterion is that the performance of the candidate device (Dri-STAT® ACP Reagent on Synchron Systems) is substantially equivalent to the predicate device (Dri-STAT® ACP Reagent on Cobas Fara). Substantial equivalence is demonstrated through the presented performance data.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Dri-STAT® ACP Reagent on Synchron Systems)
Method Comparison	Substantially equivalent to predicate device (Dri-STAT® ACP on Cobas Fara)
TACP (Synchron LX)	High correlation (R) and reasonable slope/intercept	Slope: 1.093, Intercept: 0.143, R: 0.994 (n=94)
NPAP (Synchron LX)	High correlation (R) and reasonable slope/intercept	Slope: 1.066, Intercept: -0.197, R: 0.979 (n=47)
TACP (Synchron CX)	High correlation (R) and reasonable slope/intercept	Slope: 1.075, Intercept: 0.460, R: 0.997 (n=94)
NPAP (Synchron CX)	High correlation (R) and reasonable slope/intercept	Slope: 1.088, Intercept: -0.172, R: 0.994 (n=47)
Imprecision (TACP)	Low coefficient of variation (%C.V.) for controls and human pool
Within-Run (Control 1)	Not specified explicitly, but generally <5-10% for clinical assays	4.72% C.V. (Mean: 3.81 U/L, SD: 0.18 U/L, N: 80)
Within-Run (Control 2)	Not specified explicitly	1.28% C.V. (Mean: 20.6 U/L, SD: 0.26 U/L, N: 80)
Within-Run (Control 3)	Not specified explicitly	1.35% C.V. (Mean: 37.0 U/L, SD: 0.50 U/L, N: 80)
Within-Run (Human Pool)	Not specified explicitly	1.63% C.V. (Mean: 35.5 U/L, SD: 0.58 U/L, N: 80)
Total (Control 1)	Not specified explicitly	4.99% C.V. (Mean: 3.81 U/L, SD: 0.19 U/L, N: 80)
Total (Control 2)	Not specified explicitly	1.70% C.V. (Mean: 20.6 U/L, SD: 0.35 U/L, N: 80)
Total (Control 3)	Not specified explicitly	1.73% C.V. (Mean: 37.0 U/L, SD: 0.64 U/L, N: 80)
Total (Human Pool)	Not specified explicitly	2.56% C.V. (Mean: 35.5 U/L, SD: 0.91 U/L, N: 80)
Imprecision (NPAP)	Low coefficient of variation (%C.V.) for controls and human pool
Within-Run (Control 1)	Not specified explicitly, but generally <5-10% for clinical assays	8.08% C.V. (Mean: 2.60 U/L, SD: 0.21 U/L, N: 80)
Within-Run (Human Pool)	Not specified explicitly	8.11% C.V. (Mean: 2.96 U/L, SD: 0.24 U/L, N: 80)
Total (Control 1)	Not specified explicitly	8.08% C.V. (Mean: 2.60 U/L, SD: 0.21 U/L, N: 80)
Total (Human Pool)	Not specified explicitly	9.80% C.V. (Mean: 2.96 U/L, SD: 0.29 U/L, N: 80)

Study Details

The provided document describes a study that aims to demonstrate substantial equivalence between the Dri-STAT® ACP Reagent on Synchron Systems (candidate device) and the Dri-STAT® ACP Reagent on Cobas Fara (predicate device).

Sample size used for the test set and the data provenance:
- Method Comparison Test Set:
  - TACP (Total Acid Phosphatase): 94 serum samples.
  - NPAP (Non-Prostatic Acid Phosphatase): 47 serum samples.
- Imprecision Test Set: 80 measurements for each control level and human pool for both TACP and NPAP.
- Data Provenance: Not explicitly stated, but clinical laboratory samples are typically collected in the country where the studies are performed (presumably USA given the manufacturer's location and FDA submission). The studies are retrospective or concurrent analyses of specimens, as it involves method comparison and imprecision testing on collected samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For in vitro diagnostic (IVD) assays like this, the "ground truth" is typically established by the reference method (the predicate device in this case) or known assayed values of controls, rather than human expert consensus.
Adjudication method for the test set: Not applicable. As this is an IVD assay evaluation, there is no human adjudication process involved in establishing ground truth for the samples. The predicate device's results serve as the comparison point.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is an evaluation of an in vitro diagnostic reagent, not a medical imaging or interpretation device that would involve multiple human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the entire evaluation is for the standalone performance of the Dri-STAT® ACP Reagent on Synchron Systems as an automated assay. There is no human-in-the-loop component described for its operation or result generation.
The type of ground truth used:
- Method Comparison: The "ground truth" or reference values are the results obtained from the predicate device (Dri-STAT® ACP Reagent on Cobas Fara).
- Imprecision: "Ground truth" for controls are their known assayed values, and for human pools, the mean determined value from multiple measurements.
The sample size for the training set: Not applicable. For IVD reagents, there isn't a "training set" in the machine learning sense. The device's performance characteristics are established through analytical validation studies (method comparison, linearity, imprecision), not by training an algorithm on a dataset. The reagent formulation and instrument settings are designed and optimized by the manufacturer, rather than "trained."
How the ground truth for the training set was established: Not applicable, as there is no training set in this context.

Summary

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K053612

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	DocketNumber
Dri-STAT® ReagentACP on SynchronSystems	Dri-STAT® ReagentACP On CobasFara	BeckmanCoulter, Inc.*	K821674

*Beckman Coulter, Inc., Brea, CA

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5.0 Description:

6.0 Intended Use:

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°CTotal Acid Phosphatase(TACP)	≤5.4 U/L male on predicate2.5-11.7 U/L male per literature
Reference Intervals @ 37°CNon-prostatic AcidPhosphatase (NPAP)	≤1.2 U/L male on predicate0.2-3.5 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

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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	SampleType	Slope	Inter-cept	R	n	Predicate Method
Dri-STATReagent ACPOn Synchron LXSystems	SerumTACP	1.093	0.143	0.994	94	Dri-STATReagent ACPOn Cobas Fara
Dri-STATReagent ACPOn Synchron LXSystems	SerumNPAP	1.066	-0.197	0.979	47	Dri-STATReagent ACPOn Cobas Fara
Dri-STATReagent ACPOn Synchron CXSystems	SerumTACP	1.075	0.460	0.997	94	Dri-STATReagent ACPOn Cobas Fara
Dri-STATReagent ACPOn Synchron CXSystems	SerumNPAP	1.088	-0.172	0.994	47	Dri-STATReagent ACPOn 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

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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.

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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

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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,

K053612

Regulation Number and Section

§ 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.