Abbott STREP A Controls are qualitative control materials intended for use in test systems to monitor substantial reagent failure and procedural errors. Specifically, Abbott STREP A Controls are intended for use as external controls in Abbott Rapid Immunoassays for the qualitative detection of Group A Streptococcal antigen.

Device Description

AI/ML Overview

The provided documents describe the clearance of Abbott STREP A Controls (K972182) as external controls for Abbott Rapid Immunoassays for the qualitative detection of Group A Streptococcal antigen. The primary study presented focuses on demonstrating substantial equivalence to a predicate device (K922490) and establishing the Relative Limit of Detection for the associated Strep A assays.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For the Abbott STREP A Controls (K972182):

Acceptance Criteria (for controls)	Reported Device Performance
For Positive Controls: Consistently produce correct positive results across assay lots.	Two lots of Strep A positive control gave 100% correct results across three lots of each of the Abbott Rapid Group A Strep Immunoassays (TestPack Strep A, TestPack Plus Strep A, TestPack Plus Strep A with OBC, TestPack Plus Strep A with OBC II).
For Negative Controls: Consistently produce correct negative results across assay lots.	Four lots of Strep A negative controls were tested and gave 100% correct results across three lots of TestPack Plus Strep A with OBC.
Relative Limit of Detection (of associated assays): Specific dilutions of Strep A Stock should consistently produce low-level positive results.	- TPSA: 1:667 dilution of Strep A Stock consistently produced positive results. - TP+SA & TP+SA OBC: 1:1000 dilution of Strep A Stock consistently produced positive results. - TP+SA OBC II: 1:500 dilution of Strep A Stock consistently produced positive results. (Note: This is not an acceptance criterion for the controls themselves, but rather for the assays they are designed to control. The controls are then designed relative to these limits.)

2. Sample Size Used for the Test Set and Data Provenance

Positive Controls: Two lots of Strep A positive control were tested. Each positive control lot was tested with three lots of each of the four Abbott Rapid Immunoassays (TPSA, TP+SA, TP+SA OBC, TP+SA OBC II).
Negative Controls: Four lots of Strep A negative controls were tested with three lots of TestPack Plus Strep A with OBC.
Relative Limit of Detection Study: Two lots of Strep A Stock were used. For each dilution level, two replicates were assayed on three lots of reaction discs for each of the four assays. This involves multiple individual test runs (2 stock lots * various dilutions * 2 replicates * 3 assay lots * 4 assays).
Data Provenance: The documents do not explicitly state the country of origin. Given the Abbott Laboratories address provided (Abbott Park, IL, USA) and the submission to the FDA, it is highly likely the study was conducted in the United States. The studies appear to be prospective in nature, designed specifically to demonstrate the performance of the controls and the assays.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of device and study. The "ground truth" for these tests is based on the known composition of the positive (containing Strep A antigen) and negative (not containing Strep A antigen) controls, and the established reactivity of the assays to known concentrations of Strep A. The results were "visually read at EOA [End of Assay]" but no mention of expert consensus or qualifications for reading these specific assays is provided, as they are likely standard visual interpretations based on product instructions.

4. Adjudication Method for the Test Set

Not applicable. The results were "visually read at EOA for all assays." There's no mention of a complex adjudication process as the readings are expected to be straightforward positive or negative interpretations, confirming the presence or absence of a visual signal.

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

Not applicable. This device is a diagnostic control material, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The "device" in question is a control material. The assays it controls still involve a human reading the visual results.

7. The Type of Ground Truth Used

The ground truth used is based on the known concentration and presence/absence of Group A Strep antigen in the prepared Strep A Stock dilutions and the positive/negative control materials. The Strep A Stock itself is defined as a "suspension of phenol-killed Strep A organisms." Thus, it's essentially a reference standard/known concentration approach.

8. The Sample Size for the Training Set

Not applicable in the conventional sense for an AI/algorithm. This device is a control material, and the studies performed are for its validation and the determination of the Relative Limit of Detection of the associated assays. There is no "training set" for an algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for an algorithm. The "ground truth" for the performance studies (as described in point 7) was established by the precise formulation of the Strep A Stock and control materials with known concentrations or presence/absence of Strep A antigen.

Summary

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49218

AUG 1 3 1997

510(k) Summary Abbott STREP A Controls

Summary of Safety and Effectiveness Information Supporting a Substantial Equivalent Determination

The following information as presented in the PreMarket Notification (510(k) for Abbott STREP A Controls) constitutes data supporting a substantially equivalent determination.

Substantial equivalence has been demonstrated between Abbott STREP A Controls and Abbott STREP A Controls, K922490.

The Abbott STREP A Controls, K965252 is the same as Abbott STREP A Controls, K922490. The controls are intended for use as external controls to monitor substantial reagent failure and procedural errors in Abbott Rapid Immunoassays for the qualitative detection of Group A Streptoccal antigen . Studies were performed to demonstrate that two lots of Strep A positive control gave 100% correct results across each of the Abbott Rapid Group A Strep Immunoasays (three lots each). Four lots of Strep A negative controls were tested and gave 100% correct results across three lots of TestPack Plus Strep A with OBC.

In conclusion, these data demonstrate that the Abbott STREP A Controls is as safe and effective and is substantially equivalent to Abbott STREP A Controls, K922490.

Prepared and Submitted:

Grace LeMieux (847) 937-0165 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537

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RELATIVE LIMIT OF DETECTION OF ABBOTT RAPID STREP A ASSAYS

Purpose:

To determine the Relative Limit of Detection for the Abbott Rapid Strep A assays: TestPack Strep A (TPSA), List 01301. TestPack Plus Strep A (TP+SA). List 03A59, TestPack Plus Strep A with On Board Controls (TP+SA-OBC), List 01B53, and the upcoming TestPack Plus Strep A with On Board Controls II (TP+SA-OBC II), List 05C63.

Method:

The Relative Limit of Detection was determined by identifying the dilution levels of Strep A Stock that consistently produced low level positive results on three lots of reaction discs for each assay. Strep A Stock is a suspension of phenol-killed Strep A organisms used to make the current external Positive Control, List 03078. This suspension of phenol-killed organisms is prepared at an absorbance reading (A630) of 0.52 to 0.56.

Two lots of the Strep A Stock were used in this study. Initial dilutions of 1:10, 1:100, 1:10000 were prepared using a phosphate buffer as diluent. Both the buffer and the Strep A Stock are currently used in the manufacture of Positive Control. To determine the Relative Limit of Detection, 100 uL of the dilutions were used to seed dacron swabs. This volume simulates a swab dipped into Positive Control as required by the control package insert. The swabs were extracted for one minute and tested on three lots of reaction discs on each of the four assays. Two replicates of each dilution were assayed. The results were visually read at EOA for all assays. Additional intermediate dilutions were needed to determine the Relative Limit of Detection for TPSA and TP+SA-OBC II, 1:667 for both assays and 1:500 for TP+SA-OBC II (see Table 1).

Results:

Refer to Table 1 which shows the test results for swab samples seeded with 1:10, 1:500, 1:667, 1:1,000, 1:2000 and 1:10,000 dilutions from two lots of stock Strep A suspensions.

For TPSA, the greatest dilution which consistently produced positive results was 1:667; that is, dilutions greater than 1:667 did not consistently produce positive results for the two lots of Strep A suspensions and for the three lots of TPSA used.

For TP+SA and TP+SA OBC, the greatest dilution which consistently produced positive results was 1:1000; that is, dilutions greater than 1:1000 did not consistently produce positive results for these two assays.

For TP+SA OBC II, the greatest dilution which consistently produced positive results was 1:500; that is, dilutions greater than 1:500 did not consistently produce positive results for this assay.

Summary:

These data suggest the manufacture of a "new" positive control made at approximately ten times (one log above) the relative limits of detection for the four assays . This corresponds to a 1:100 dilution of the stock Strep A suspension (refer to Table 2).

Faxed to FDA on 4-16-97

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AUG 1 3 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Grace LeMieux Sr. Regulatory Specialist ADD Regulatory Affairs 200 Abbott Park Road Dept. 9V6. Bldg. AP31 Abbott Park, IL 60064-3537

Re: K972182

Trade Name: Abbott STREP A Controls Regulatory Class: I Product Code: MJZ Dated: May 28, 1997 Received: May 29, 1997

Dear Ms. LeMieux:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K972182

Device Name: Abbott STREP A Controls

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	✓
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Over-The-Counter Use
	(Optional Format 1-2-96)

	(Division Sign-Off) Division of Clinical Laboratory Devices
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510(k) Number	972187
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Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.